Interlink 303345Recalls & reported problems
Becton, Dickinson And Company · Blunt Plastic Cannula · Class 2
Quick summary
This is a BD Interlink blunt plastic cannula, used to draw medicine from vials. Many of the 83 reports describe leaks and splashes, tips breaking off, and foreign matter found inside the device, and some describe vial stoppers being pushed into vials. There are no deaths and no injuries. No recalls name this device. Reports fell in the last 12 months, with 1 compared with 5 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 83
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00382903033454), received between Dec 1, 2017 and Feb 16, 2026 — classified as 83 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (39 reports).
2 other recalls cover devices cleared under the same FDA submission (K974363); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash39
- Device Contamination with Chemical or Other Material20
- Break17
- Defective Component7
- Contamination4
- Crack3
- Device Markings/Labelling Problem2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
- No Known Impact Or Consequence To Patient32
- No Patient Involvement14
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 16, 2026Contamination
IT IS REPORTED FOREIGN MATTER. DESCRIPTION: BEDSIDE RN WAS ABOUT TO PLACE PIV IN THE ED ON A PATIENT AND WHEN OPENING, NOTICED THE BLUNT TIP SHOWED A CLEAR BROWN SUBSTANCE INSIDE THE DEVICE. RN GOT A NEW BLUNT TIP AND SYRINGE TO USE. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24345270 ↗MalfunctionFeb 12, 2025Defective Component; Defective Component
ADDITIONAL INFORMATION RECEIVED. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21364636 ↗MalfunctionFeb 4, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 21303429 ↗MalfunctionDec 3, 2024Break; Break
NO ADDITIONAL INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833378 ↗MalfunctionNov 25, 2024Break; Defective Component; Break; Defective Component
ADDITIONAL INFORMATION RECEIVED BY CUSTOMER: IN FURTHER SPEAKING WITH THE CHARGE NURSE, SHE SAID THAT WHEN SHE WAS DRAWING UP THE VACCINE WITH THE PLASTIC CANNULA IT WAS NOT EASY TO USE. HAD TO PUT MORE PRESSURE TO PUSH INTO THE VACCINE RUBBER STOPPER. PIECES OF THE VACCINE STOPPER WERE CUT AND WENT INTO VACCINE. VACCINE VIAL WAS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770823 ↗MalfunctionNov 25, 2024Break; Defective Component; Break; Defective Component
MATERIAL #:303345 AND BATCH#: 4178837. IT WAS REPORTED BY CUSTOMER THAT 2 BX 303345 ARE BREAKING WHEN TRYING TO ADMINISTER A VACCINE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. LOT BOX 4178837. 2 BX 303345 ARE BREAKING WHEN TRYING TO ADMINISTER A VACCINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770816 ↗MalfunctionJul 26, 2024Defective Component; Defective Component
MATERIAL # 303345 BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE TIPS OF THE BLUNT PLASTIC CANNULA BREAKING OFF AS WELL AS ISSUES WITH THE VIAL STOPPERS BEING PUSHED INTO THE VIAL. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. SALES REP STATES SHE IS MEETING WITH (B)(6) SYSTEM. THE PHARMACY THERE IS HAVING ISSUES WITH THE BD INTERLINK BLUNT PLASTIC CANNULA REF 303345. THEY ARE HAVING ISSUES WITH THE TIPS OF THE BLUNT PLASTIC CANNULA BREAKING OFF AS WELL AS ISSUES WITH THE VIAL STOPPERS BEING PUSHED INTO THE VIAL. REP STATES THEY DID INFORM HER THEY ARE INSERTING THE CANNULA AT AN ANGLE RATHER THAN 90 DEGREES. REP LOOKING FOR ANY EDUCATIONAL MATERIAL, IFU, OR INFORMATION ON HOW THEY SHOULD BE USING THIS PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19837904 ↗MalfunctionJul 26, 2024Break; Break
MATERIAL #: 303345, BATCH #: UNKNOWN. IT WAS REPORTED, BY CUSTOMER. THAT THE TIPS OF THE BLUNT PLASTIC CANNULA BREAKING OFF. AS WELL AS, ISSUES WITH THE VIAL STOPPERS BEING PUSHED INTO THE VIAL. VERBATIM: RCC RECEIVED, A COMPLAINT VIA PHONE. PIR ATTACHED. SALES REP STATES, SHE IS MEETING WITH (B)(6). THE PHARMACY THERE IS HAVING ISSUES WITH THE BD INTERLINK BLUNT PLASTIC CANNULA REF 303345. THEY ARE HAVING ISSUES WITH THE TIPS OF THE BLUNT PLASTIC CANNULA BREAKING OFF. AS WELL AS, ISSUES WITH THE VIAL STOPPERS BEING PUSHED INTO THE VIAL. REP STATES, THEY DID INFORM HER, THEY ARE INSERTING THE CANNULA AT AN ANGLE RATHER THAN 90 DEGREES. REP LOOKING FOR ANY EDUCATIONAL MATERIAL, IFU OR INFORMATION ON HOW THEY SHOULD BE USING THIS PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19837477 ↗MalfunctionJan 24, 2024Defective Component; Device Contamination with Chemical or Other Material; Defective Component; Device Contamination with Chemical or Other Material
MATERIAL#: 303345 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THESE BLUNT PLASTIC CANNULAS TO DRAW UP PROPOFOL FROM A VIAL "RUBBER CORING" OCCURS. WHEN THE VIAL IS PUNCTURED WITH THE BLUNT PLASTIC CANNULA, A SMALL PIECE OF RUBBER FALLS INTO THE VIAL AND CAN THEN BE ASPIRATED INTO THE SYRINGE AND INJECTED INTO THE PATIENT UNKNOWINGLY. IT IS VERY SMALL, AND YOU WOULD HAVE TO EXAMINE THE SYRINGE AND VIAL CAREFULLY TO ENSURE THE RUBBER IS NOT EVIDENT. HE HAS PROVIDED ME WITH PICTURES OF THE RUBBER INSIDE SEVERAL SYRINGES, SEVERAL VIALS OF PROPOFOL WITH PIECES OF THE RUBBER FLOATING INSIDE THEM AND LITERATURE DOCUMENTING AN INCREASE RISK OF "CORING" WHEN USING THESE BLUNT PLASTIC CANNULAS AS OPPOSED TO THE BLUNT NEEDLES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CRNA THAT IS VERY ADAMANT THAT WHEN USING THESE BLUNT PLASTIC CANNULAS TO DRAW UP PROPOFOL FROM A VIAL "RUBBER CORING" OCCURS. WHEN THE VIAL IS PUNCTURED WITH THE BLUNT PLASTIC CANNULA, A SMALL PIECE OF RUBBER FALLS INTO THE VIAL AND CAN THEN BE ASPIRATED INTO THE SYRINGE AND INJECTED INTO THE PATIENT UNKNOWINGLY. IT IS VERY SMALL, AND YOU WOULD HAVE TO EXAMINE THE SYRINGE AND VIAL CARE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18569676 ↗MalfunctionJan 5, 2024Defective Device; Defective Device
IT WAS REPORTED THAT THE BD CANNULA BLUNT PLASTIC NEEDLE WAS CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE CORING, CUSTOMER CALLED IN WANTING SAFETY DATA REGARDING CORING OF BLUNT NEEDLE, DID NOT WANT TO FILE A COMPLAINT." ADVISED CUSTOMER THAT THIS IS A COMPLAINT AND REPORTABLE ISSUE. "CUSTOMER WAS NOT BEING COOPERATIVE AND REFUSED TO PROVIDE THE FACILITY NAME."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18451530 ↗MalfunctionJun 13, 2023Contamination; Contamination
IT WAS REPORTED THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ISSUE WAS OBSERVED TODAY WHEN USING ONE OF THE NEW VIAL ASPIRATOR NEEDLES ¿ A RUBBER CORE APPEARED IN THE MEDICATION AFTER THE RUBBER CAP WAS SPIKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17121338 ↗MalfunctionMay 1, 2023Defective Component; Defective Component
IT WAS REPORTED THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA WAS DAMAGED, SMALL PIECE OF METAL FELL INTO THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HIS COMPLAINT IS THAT WHEN YOU PUNCTURE THE VIAL WITH THE CANNULA A SMALL PIECE OF METAL FALLS INTO THE VIAL WHICH COULD BE ASPIRATED INTO THE SYRINGE AND THEN BE INJECTED INTO A PATIENT VIA IV ACCESS PORT. I DID WITNESS THE SMALL PIECE OF METAL SITTING AT THE BOTTOM OF THE VIAL AFTER USE WITH THE CANNULA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16849318 ↗MalfunctionFeb 14, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE BD INTERLINK¿ BLUNT PLASTIC CANNULA BROKE OFF IN THE HUB OF THE LINE DRAW DURING USE AND LODGED IN THE RUBBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING ARTERIAL LINE BLOOD DRAWS, THE TIP OF A BLUNT FILL SNAPPED OFF IN THE HUB OF THE RUBBER PORTION OF THE LINE DRAW. THE TIP WAS LODGED IN THE RUBBER AND COULDN'T BE REMOVED. THE LINE NEEDED TO BE EXCHANGED URGENTLY AS TO NOT LOSE THE ARTERIAL LINE AND HAVE IT CLOT OFF. UNABLE TO FLUSH LINE AS OF RISK TO PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16376300 ↗MalfunctionFeb 8, 2023Contamination; Contamination
IT WAS REPORTED THAT A DOZEN BD INTERLINK¿ BLUNT PLASTIC CANNULAS HAD BLACK SPECKS IN THE PROPOFOL FOUND DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED VIA PHONE THAT "WHEN IT PUSHES THROUGH THE RUBBER YOU CAN SEE A BLACK SPECK IN THE PROPOFOL." CUSTOMER IS WONDERING IF THERE IS A FILTER THAT STOPS THE BLACK SPECK. CUSTOMER STATES THAT THEY HAVE HAD THIS ISSUE WITH AT LEAST A DOZEN CANNULAS. THEY STARTED GETTING THIS PRODUCT LAST WEEK. THERE HAS BEEN NO PATIENT IMPACT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16320020 ↗MalfunctionJul 15, 2022Contamination; Contamination
IT WAS REPORTED THAT A BD BLUNT PLASTIC CANNULA EXPERIENCE CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE BLUNT CANNULAS WILL CUT A SMALL PIECE OF THE RUBBER TOPS OF PROPOFOL VIALS DISPENSED BY HOSPIRA. THESE SMALL PIECES OF RUBBER CAN BE DRAWN INTO THE SYRINGE AND PUSHED INTO PATIENTS"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15034045 ↗MalfunctionMay 19, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE WHEN THE BD INTERLINK¿ BLUNT PLASTIC CANNULA IS PUSHED INTO A VIAL, IT WILL BREAK OFF A PIECE OF THE RUBBER FROM INSIDE THE VIAL (CORING). THIS OCCURRED MULTIPLE TIMES, HOWEVER, NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR RNS BROUGHT UP A CONCERN ABOUT THE BD BLUNT PLASTIC CANNULA. HE SAID THIS IS THE 2ND TIME HE HAS NOTICED THAT THE BLUNT CANNULA, WHEN PUSHED INTO A VIAL, WILL BREAK OFF A PIECE OF THE RUBBER FROM INSIDE THE VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14435056 ↗MalfunctionMay 18, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BY CUSTOMER THAT THE BD INTERLINK¿ BLUNT PLASTIC CANNULA HAD CORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD A STOPPER CORING ISSUE REPORTED TO US BY OUR ANESTHESIA TEAM WHEN THEY USED THE ATTACHED BLUNT POINT DEVICE TO WITHDRAW LIQUID MEDICATION FROM A DRUG VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14431574 ↗MalfunctionApr 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED BD INTERLINK¿ BLUNT PLASTIC CANNULA HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BLUNT TIP TOOK A CHUNK OF RUBBER OUT OF THE TOP OF THE VIAL, AND IT WAS SUCKED INTO THE SYRINGE WITH THE MEDICATION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14053404 ↗MalfunctionApr 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 1 BD BLUNT PLASTIC CANNULA HAD CORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED THAT A RUBBER CORE PUSHED THROUGH THE NEEDLE ON A VILE OF PROPOFOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13983999 ↗MalfunctionApr 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD INTERLINK¿ BLUNT PLASTIC CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ACCESSING/DRAWING UP MEDICATION IS PUSHING A PIECE OF RUBBER INTO THE MEDICATION VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13982599 ↗MalfunctionSep 14, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT 3 BD INTERLINK¿ BLUNT PLASTIC CANNULAS' TIPS BROKE OFF: 2 INTO THE VIALS WHEN DRAWING UP MEDICINE, AND 1 WHILE OPENING THE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED THEY USED THIS CANNULA AND SOME OF THE TIPS OF THE CANNULAS ARE BREAKING OFF INTO THE VIALS WHEN THEY ARE DRAWING THEM UP. TWO OCCURRENCES HAPPENED WHEN DRAWING UP FROM A VIAL THE TIP BROKE OFF IN THE VIAL AND 1 OCCURRENCE WAS WHEN OPENING THE CANNULA TIP BROKE INSTANTLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12468565 ↗MalfunctionSep 3, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 2 BD¿ BLUNT PLASTIC CANNULAS EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE CANNULAS HAVE PROVEN TO NOT BE AN ACCEPTABLE PRODUCT IN OUR HEALTH SYSTEM. FROM THE DAY WE PUT THESE ON OUR SHELVES, WE HAVE RECEIVED NOTHING BUT NEGATIVE FEEDBACK AND OUR END USERS HAVE COMPLETELY LOST CONFIDENCE IN THIS PRODUCT AND WE WILL NO LONGER BE ABLE TO UTILIZE THEM. WE HAVE ALSO RECEIVED COUNTLESS EMAILS AND PHONE CALLS REGARDING THESE. I WAS EVEN GETTING CALLS THROUGHOUT THE WEEKENDS. OUR SUPPLY CHAIN SPECIALISTS WHO SUPPLY OUR UNITS CONTINUE TO RECEIVE NEGATIVE FEEDBACK AS WELL. NURSE WAS RECONSTITUTING ANCEF W/ BLUNT PLASTIC CANNULA AND NOTICED PIECE OF RUBBER TOP WAS FLOATING IN ANCEF VIAL. SAME THING HAPPENED TO SAME NURSE AGAIN WITH DIFFERENT VIAL OF ANCEF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422308 ↗MalfunctionSep 3, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT 2 BD¿ BLUNT PLASTIC CANNULAS EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE, AND INTERLINK DAMAGING THE CONNECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE CANNULAS HAVE PROVEN TO NOT BE AN ACCEPTABLE PRODUCT IN OUR HEALTH SYSTEM. FROM THE DAY WE PUT THESE ON OUR SHELVES, WE HAVE RECEIVED NOTHING BUT NEGATIVE FEEDBACK AND OUR END USERS HAVE COMPLETELY LOST CONFIDENCE IN THIS PRODUCT AND WE WILL NO LONGER BE ABLE TO UTILIZE THEM. WE HAVE ALSO RECEIVED COUNTLESS EMAILS AND PHONE CALLS REGARDING THESE. I WAS EVEN GETTING CALLS THROUGHOUT THE WEEKENDS. OUR SUPPLY CHAIN SPECIALISTS WHO SUPPLY OUR UNITS CONTINUE TO RECEIVE NEGATIVE FEEDBACK AS WELL. RN PULLED A FENTANYL VIAL FROM THE 26 SIDE OMNICELL AND WHEN SHE USED THE BLUNT PLASTIC CANNULA TO PULL THE MEDICATION OUT OF THE VIAL, THE PLUNGER COMPLETELY FELL OUT OF THE TOP OF THE VIAL AND DOWN INTO THE VIAL. THE RN REPORTED SHE HAD TO PUT SOME PRESSURE ON THE PLUNGER TOP TO GET THE BLUNT CANNULA TO PUNCTURE THROUGH THE PLUNGER OF THE VIAL. THESE ARE DIFFERENT BLUNT CANNULAS THEN WHAT WE NORMALLY STOCK. OUR NORMAL STOCK OF GRAY CAPPED BLUNT CANNULAS ARE ON BA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422302 ↗MalfunctionSep 3, 2021Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT 2 BD¿ BLUNT PLASTIC CANNULAS EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND INTERLINK DAMAGING THE CONNECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE CANNULAS HAVE PROVEN TO NOT BE AN ACCEPTABLE PRODUCT IN OUR HEALTH SYSTEM. FROM THE DAY WE PUT THESE ON OUR SHELVES, WE HAVE RECEIVED NOTHING BUT NEGATIVE FEEDBACK AND OUR END USERS HAVE COMPLETELY LOST CONFIDENCE IN THIS PRODUCT AND WE WILL NO LONGER BE ABLE TO UTILIZE THEM. WE HAVE ALSO RECEIVED COUNTLESS EMAILS AND PHONE CALLS REGARDING THESE. I WAS EVEN GETTING CALLS THROUGHOUT THE WEEKENDS. OUR SUPPLY CHAIN SPECIALISTS WHO SUPPLY OUR UNITS CONTINUE TO RECEIVE NEGATIVE FEEDBACK AS WELL. THIS RN WAS PULLING UP FENTANYL IN A VIAL WITH NEW BLUNT TIP NEEDLES. THE BLUNT TIP PUNCTURED THROUGH THE TOP OF THE VIAL, BREAKING IT AND CAUSING THE MEDICATION TO SPILL, AS WELL AS DIFFICULTY PULLING THE MEDICATION OUT OF THE VIAL. WHEN USING BLUNT NEEDLE, RUBBER STOPPER PUSHED THROUGH THE LID INTO THE VIAL. MEDICATION DISCARDED/WASTED AND NEW VIAL WAS PULLED FROM OMNICELL FOR PATIENT ADMINISTRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422179 ↗MalfunctionSep 3, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD¿ BLUNT PLASTIC CANNULA EXPERIENCED AN INTERLINK THAT DAMAGED THE CONNECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE CANNULAS HAVE PROVEN TO NOT BE AN ACCEPTABLE PRODUCT IN OUR HEALTH SYSTEM. FROM THE DAY WE PUT THESE ON OUR SHELVES, WE HAVE RECEIVED NOTHING BUT NEGATIVE FEEDBACK AND OUR END USERS HAVE COMPLETELY LOST CONFIDENCE IN THIS PRODUCT AND WE WILL NO LONGER BE ABLE TO UTILIZE THEM. WE HAVE ALSO RECEIVED COUNTLESS EMAILS AND PHONE CALLS REGARDING THESE. I WAS EVEN GETTING CALLS THROUGHOUT THE WEEKENDS. OUR SUPPLY CHAIN SPECIALISTS WHO SUPPLY OUR UNITS CONTINUE TO RECEIVE NEGATIVE FEEDBACK AS WELL. WHILE USING THE BD BLUNT PLASTIC CANNULA (LOT 1015091) TO DRAW UP FENTANYL, THE RUBBER TOP OF THE FENTANYL BECAME COMPLETELY DISLODGED AND FELL INTO THE VIAL. THESE BLUNT CANNULAS ARE VERY HARD TO PUSH INTO MEDICATION VIALS CAUSING DISRUPTION IN THE INTEGRITY OF THE VIALS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12422082 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K974363. One submission often covers many models, so check the product and lot details in each record.
- Z-1055-2015 · Dec 19, 2014 · TerminatedBD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4
- Z-1461-06 · Jun 21, 2006 · TerminatedBD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380.
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.