N/A 309620Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00382903096206), received between Oct 20, 2017 and Apr 8, 2026 — classified as 3 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT THEY RECEIVED A SYRINGE WITH SOME RESIDUE ON THE INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817151 ↗
• MalfunctionDec 9, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD SYRINGE CATHETER TIP 50ML PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED 50 ML SYRINGE CATHETER TIP REF (B)(4). LOT 5121908 ISSUE: THERE IS A DOMINANT BLACK TAPE OVER THE ITEM PACKAGING AND THE SYRINGES WITH THIS TYPE OF TAPE ARE NOT SEALED PROPERLY. THIS ITEM COULD NOT BE USED TO DUE TO CONCERN OF QUALITY, CLEANLINESS, AND PATIENT SAFETY. IT WAS WITHIN THE SAME PACKAGE OF OTHERS AND OTHER SYRINGES IN THE SAME BOX DID NOT LOOK DIRTY OR AFFECTED. ADDITIONAL INFORMATION PROVIDED: FOR (B)(4). I WAS GIVEN THE ITEM ON 11/04/2025. 2. CORRECT LOT # 5171908 3. THERE WAS NO DAMAGE TO THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756295 ↗
• MalfunctionNov 10, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE BD SYRINGE CATHETER TIP 50ML HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309620 BATCH#: UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED INJURIES OR ADVERSE EVENT: NO ITEM: 309620 QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: . PO: (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: 50 ML LUER LOCK SYRINGE TIP BROKE OFF IN ECMO CANNULA CONNECTOR PIECE, UNABLE TO SCREW DEAD-END CAP BACK ON CONNECTOR PIECE D/T TIP BEING STUCK INSIDE. HAD TO CUT INTO CIRCUIT AND PLACE A NEW CONNECTOR IN ORDER TO RE-ESTABLISH FLOWS TO THE PATIENT AND CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23518550 ↗
• MalfunctionAug 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: IT WAS REPORTED THAT NEXT, I SEND FOR YOUR SOCIALIZATION THE FOLLOWING INCIDENT THAT IS PRESENTED IN THE SERVICE OF CENTRAL LIMONAR PHARMACY WITH THE ITEM: 1000000552 SYRINGE 50ML CATHETER TIP 309620 BD LOT: 5043318 (1 UND), TAKING INTO ACCOUNT THE ABOVE WE ARE ATTENTIVE TO TECHNICAL RESPONSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22904326 ↗
• MalfunctionApr 22, 2025Packaging Problem; Packaging Problem

  MATERIAL #:309620. BATCH#:4172759. IT WAS REPORTED BY CUSTOMER THAT THEY FOUND A PUNCTURES IN PLASTIC PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE FOLLOW UP WITH (B)(6) FOR THE PRODUCT CONCERN OUTLINED BELOW WITHIN 3 BUSINESS DAYS; AND ADVISE OF ANY SPECIAL SHIPPING INSTRUCTIONS FOR PICK UP, COURIER OR DISCARDING OF PRODUCT. PLEASE INVESTIGATE AND FOLLOW UP WITH A WRITTEN REPORT FROM YOUR QUALITY ASSURANCE AS TO YOUR FINDINGS AND RESOLUTIONS. PRODUCT CONCERN TICKET NUMBER: (B)(4). DATE OF INCIDENT: (B)(6) 2024. HOSPITAL: (B)(6). DEPARTMENT: (B)(6). PRODUCT: SYR LL TIP 50CC. VMID: (B)(4). LOT NUMBER: MULTIPLE LOTS. PRODUCT EXPIRY DATE: 31-MAY-2029. NUMBER OF DEFECTIVE PRODUCT(S): 1. IS SAMPLE AVAILABLE: NO. CONCERN DESCRIPTION: LOOKS LIKE SMALL PUNCTURES IN PLASTIC PACKAGING. THANK YOU IN ADVANCE FOR YOUR FOLLOW-UP ON THIS PRODUCT CONCERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885185 ↗
• MalfunctionMar 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589996 ↗
• MalfunctionFeb 3, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290645 ↗
• MalfunctionJan 23, 2025Contamination; Contamination

  NO ADDITIONAL INFORMATION RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21220516 ↗
• MalfunctionJan 16, 2025Break; Break

  MATERIAL#: 309620, BATCH#: 4247871. RCC RECEIVED A COMPLAINT VIA EMAIL. SYRINGE TIP BROKE OFF.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21167270 ↗
• MalfunctionDec 16, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938170 ↗
• MalfunctionNov 19, 2024Crack; Crack

  MATERIAL # 309620. BATCH # UNKNOWN. VERBATIM: THERE WAS AN INCIDENTAL FINDING DURING THE INVESTIGATION OF PR (B)(4) THAT REQUIRES A NEW PR TO BE OPENED. CAN YOU PLEASE OPEN A NEW PR FOR MATERIAL 309620, LOT UNKNOWN AND BARREL CRACKED. PLEASE HAVE ME AS THE CONTACT, DO NOT SEND AN ACKNOWLEDGEMENT LETTER, DO NOT DO ANY DUE DILIGENCE OR MARK TO SEND A CLOSURE LETTER. THIS PR WILL JUST BE FOR PROPER REPORTING OF THE DEFECT FOUND. PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS. THANK YOU!

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20725654 ↗
• MalfunctionNov 7, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630166 ↗
• MalfunctionOct 29, 2024Material Integrity Problem; Material Integrity Problem

  MATERIAL#: 309620, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT ENTERIC TUBE WAS A LITTLE CLOGGED WITH MIRALAX (I COULD SEE THE SMALL BALL OF MEDICATION IN THE SUMP TUBE BEFORE IT ENTERED THE NOSE), I FILLED THE SYRINGE WITH WARM WATER, TRIED TO FLUSH, TRIED TO ASPIRATE/PULL BACK A LITTLE TO LOOSEN THE CLOT THEN DID A BIGGER FLUSH WITH A LITTLE MORE PRESSURE, AND THE CATH TIP LITERALLY POPPED OFF. I DIDN'T FEEL LIKE I WAS PUSHING CRAZY HARD, A LITTLE MORE THAN USUAL BUT IT WASN'T HULK STRENGTH BY ANY MEANS. IT WAS THE CATHETER TIP SYRINGE. THE TIP WAS STUCK IN THE SUMP TUBE OPENING, BUT EASILY CAME OUT WITH SOME HEMOSTATS. WITH A NEW SYRINGE I TRIED THE SAME THING, AND THE CLOT CLEARED AND THE TUBE FLUSHED NORMALLY. RCC RECEIVED A COMPLAINT VIA EMAIL. 'ENTERIC TUBE WAS A LITTLE CLOGGED WITH MIRALAX (I COULD SEE THE SMALL BALL OF MEDICATION IN THE SUMP TUBE BEFORE IT ENTERED THE NOSE), I FILLED THE SYRINGE WITH WARM WATER, TRIED TO FLUSH, TRIED TO ASPIRATE/PULL BACK A LITTLE TO LOOSEN THE CLOT THEN DID A BIGGER FLUSH WITH A LITTLE MORE PRESSURE, AND THE CATH TIP LITERALLY POPPED OFF. I DIDN'T FEEL LIKE I WAS PUSHING CRAZY HARD, A LITTLE MORE THAN USUAL BUT IT WASN'T HULK STRENG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558771 ↗
• MalfunctionOct 7, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL # 309620 BATCH # 4172751 IT WAS REPORTED BY CUSTOMER THAT BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. VERBATIM: I WANTED TO BRING TO YOUR ATTENTION TWO ITEMS FOUND IN 3 MAIN¿S CLEAN UTILITY ROOM. THE FIRST IS A BD 50 ML SYRINGE WITH A CATHETER TIP. INSIDE THE CAP HAS BROWN SEDIMENT. PICTURES ARE INCLUDED BELOW. THE NURSE WAS OPENING UP THE PACKAGE, WHICH WAS SEALED, AND FOUND THE CAP TO BE CONTAMINATED. THE SECOND ITEM IS A LUER LOCK SYRINGE PACKED OUT ON SHELVES IN NO PACKAGING OR IN ANY BAG. THESE SYRINGES ARE USED FOR FEEDING TUBES, AND PACKED OUT WITH NO COVERING THEY ARE EXPOSED TO POTENTIAL DUST OR CONTAMINANTS. I HAVE INCLUDED PICTURES OF BOTH PRODUCTS AS WELL AS THE PACKAGING FOR THE BD SYRINGE WITH THE LOT NUMBER. THANK YOU,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20389256 ↗
• MalfunctionAug 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MATERIAL #: 309653, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT PHARMACY NOTICED THAT A CERTAIN LOT OF THE BD# 309653 DID NOT HAVE SCALE MARKINGS ON THEM. AS THEIR SUPPLY CHAIN TEAM BEGAN INSPECTING THIS PRODUCT NUMBER AND LOT ACROSS THE DIVISION, THEY THEN NOTICED THAT BD# 309620 OF A CERTAIN LOT ALSO DID NOT HAVE SCALE MARKINGS VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. PHARMACY NOTICED THAT A CERTAIN LOT OF THE BD# 309653 DID NOT HAVE SCALE MARKINGS ON THEM. AS THEIR SUPPLY CHAIN TEAM BEGAN INSPECTING THIS PRODUCT NUMBER AND LOT ACROSS THE DIVISION, THEY THEN NOTICED THAT BD# 309620 OF A CERTAIN LOT ALSO DID NOT HAVE SCALE MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19923450 ↗
• MalfunctionJul 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 309620; BATCH#: 4080096. IT WAS REPORTED BY CUSTOMER THAT PHARMACY NOTICED THAT A CERTAIN LOT OF THE BD# 309653 DID NOT HAVE SCALE MARKINGS ON THEM. AS THEIR SUPPLY CHAIN TEAM BEGAN INSPECTING THIS PRODUCT NUMBER AND LOT ACROSS THE DIVISION, THEY THEN NOTICED THAT BD# 309620 OF A CERTAIN LOT ALSO DID NOT HAVE SCALE MARKINGS. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. PHARMACY NOTICED THAT A CERTAIN LOT OF THE BD# 309653 DID NOT HAVE SCALE MARKINGS ON THEM. AS THEIR SUPPLY CHAIN TEAM BEGAN INSPECTING THIS PRODUCT NUMBER AND LOT ACROSS THE DIVISION, THEY THEN NOTICED THAT BD# 309620 OF A CERTAIN LOT ALSO DID NOT HAVE SCALE MARKINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824711 ↗
• MalfunctionMay 1, 2024Contamination; Device Contamination with Chemical or Other Material; Contamination; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL: 309620 BATCH#: 3273719 IT WAS REPORTED BY THE CUSTOMER THAT UNKNOWN SUBSTANCE FOUND IN 50ML SYRINGE. SYRINGE IS UNSTERILE. VERBATIM: UNKNOWN SUBSTANCE FOUND IN 50ML SYRINGE. SYRINGE IS UNSTERILE. COMMENTS ON 25/04/2024 1. LOT NUMBER IS 3273719 2. DATE WAS 4-24-24 3. NO INJURY TO PATIENT OR STAFF. ITEM WAS NOT USED/OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219845 ↗
• MalfunctionDec 27, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIALS#: 309620 BATCH#: 3139683. IT WAS REPORTED BY THE CUSTOMER THAT A PARTICULATE ON THIS 50 ML CATHETER TIP SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I AM WRITING TO REPORT THE PRESENCE OF A PARTICULATE ON THIS 50 ML CATHETER TIP SYRINGE. COMPOUNDING TECH BROUGHT IT TO MY ATTENTION. CANNOT TELL IF IT¿S IN THE STERILE FIELD OR MELTED INTO THE PLASTIC. I NO LONGER HAVE THE PRODUCT IN MY POSSESSION. NO PATIENT INVOLVEMENT. LOT NUMBER: 3139683.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18397596 ↗
• MalfunctionOct 5, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  (B)(4) ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 309620, BATCH#: 3096960. IT WAS REPORTED BY CUSTOMER THAT BD 50 ML CATHETER TIP SYRINGE WAS FOUND TO HAVE CONTAMINANT ON THE TIP OF IT BEFORE THE PACKAGE WAS EVEN OPENED. VERBATIM: ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. SITUATION: ISSUE: BD 50 ML CATHETER TIP SYRINGE WAS FOUND TO HAVE CONTAMINANT ON THE TIP OF IT BEFORE THE PACKAGE WAS EVEN OPENED. BACKGROUND: EVENT DATE: 9/22/2023. IH #: 93018406. MFG #: 309620. DESCRIPTION: SYRINGE 50ML CATH TIP 309620. SAMPLE AVAILABLE : Y (IF SAMPLE IS AVAILABLE AND WOULD LIKE IT SENT FOR YOUR EVALUATION, PLEASE REPLY ALL AND ATTACH A RETURN SHIPPING LABEL VIA EMAIL). LOT #: 3096960. ASSESSMENT: WAS THERE INJURY? N. NAME OF FACILITY : XXX. MAIN CONTACT NAME AND PHONE NUMBER:XXX. FRONTLINE CAREGIVERS CONTACT INFORMATION (IF APPLICABLE): ACCOUNT # PO PURCHASED ON: (B)(4). RECOMMENDATION/REQUEST: INTERMOUNTAIN¿S NEXT STEPS: SUPPLIER¿S NEXT STEPS: IF YOU WOULD LIKE THE PRODUCT RETURNED, PLEASE REPLY ALL WITH A RETURN SHIPPING LABEL ATTACHED WITHIN 10 DAYS THAT THIS EMAIL WAS SENT (9/25/2023). IF NO LABEL IS RECEIVED, PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882496 ↗
• MalfunctionSep 29, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE PLUNGER WAS DIFFICULT TO MOVE WHILE ASPIRATING AND PUSHING OUT FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE IS DIFFICULT TO USE, IT DOES NOT GLIDE SMOOTHLY AND IS VERY TIGHT WHEN ASPIRATING AND PUSHING FLUIDS OCCURRENCES: 1 EACH... NO ADVERSE EVENT REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848145 ↗
• MalfunctionAug 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND INSIDE THE BD¿ CATHETER TIP SYRINGE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER FOUND DEBRIS INSIDE A STERILE SYRINGE. FOUND BEFORE USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17529988 ↗
• MalfunctionOct 4, 2022Melted; Melted

  IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE STARTED TO "DISINTEGRATE" AFTER BEING DROPPED IN AN UNSPECIFIED SOLUTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAD A TECHNICIAN DROP THE SYRINGE IN A SOLUTION AND THE SYRINGE STARTED TO DISINTEGRATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541324 ↗
• MalfunctionSep 30, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BD¿ CATHETER TIP SYRINGE PLUNGER WAS TIGHT AND DIFFICULT TO MOVE DURING THE NASAL GASTRIC ASPIRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE IS TOO TIGHT. CUSTOMER COMPLAINT DIFFICULTY TO DO NASAL GASTRIC TUBE ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15518732 ↗
• MalfunctionMay 10, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD¿ CATHETER TIP SYRINGE STERILE, SINGLE USE THE SYRINGE SEPARATED DURING USE AND CAUSED LEAKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MANY A TIMES, THE SYRINGE WILL ¿POP¿ OUT DURING NG FEEDING ESPECIALLY FOR PATIENTS USING THE FEEDING TUBE, CAUSING THE MILK TO OVERFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349289 ↗
• MalfunctionMay 10, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING BD¿ CATHETER TIP SYRINGE STERILE, SINGLE USE THE PLUNGER WAS DIFFICULT TO MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS VERY TIGHT THEREFORE DIFFICULT TO WITHDRAW AND PUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14349167 ↗