N/A 303369Recalls & reported problems
Becton, Dickinson And Company · Threaded Lock Cannula · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a BD Threaded Lock cannula, a single-lumen hypodermic needle used to connect to IV lines and infusion bags. The 44 reports mostly describe fluid leaking or splashing at the connection, the cannula breaking, and fluid that would not flow at all; one report mentions a pulmonary embolism and one injury. No deaths were reported. No recalls name this device, and reports were filed from January 2018 through May 2022.
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
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00382903033690), received between Jan 31, 2018 and May 7, 2022 — classified as 1 injury, 43 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (32 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash32
- Break16
- Complete Blockage3
- Device Contamination with Chemical or Other Material2
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Loose or Intermittent Connection1
Patient problems
- No Known Impact Or Consequence To Patient24
- No Consequences Or Impact To Patient10
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions3
- Pulmonary Embolism1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2022Material Perforation; Material Perforation
IT WAS REPORTED THAT 80 BD¿ THREADED LOCK CANNULAS HAD POOR PACKAGING PERFORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DEFECTIVE SEALING." VIA BDJ INVESTIGATION: "THE SEALING OF MANY PACKAGES WAS ENTIRELY CRIMPED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14317452 ↗MalfunctionJan 31, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHEN USING THE BD CANNULA INTERLINK THREADED LOCK, THE DEVICE EXPERIENCED FLOW ISSUES. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT A FLOW ISSUE. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, THE HCP CONNECTED A THREADED LOCK CANNULA TO THE INJECTION SITE OF A2N3374-ZBA BUT THE FLUID DIDN'T FLOW. THE HCP THEN USED ANOTHER THREADED LOCK CANNULA BUT THE FLUID STILL DIDN¿T FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13403002 ↗MalfunctionFeb 25, 2021Complete Blockage; Complete Blockage
IT WAS REPORTED THAT CANNULA INTERLINK THREADED LOCK HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INFUSION WITH THE USE OF INTERLINK THREADED CANNULA, FLUIDS DIDN'T FLOW. WHEN USING ANOTHER PRODUCT, FLUIDS FLOWED WITH NO PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11382173 ↗MalfunctionDec 4, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 3 BD¿ THREADED LOCK CANNULAS HAD LOOSE CONNECTIONS WITH THEIR MATING COMPONENTS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DURING USING THE THREADED LOCK CANNULA, THE HCP NOTICED THAT ITS CONNECTION BECAME LOOSE AND THUS STOPPED THE USE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10946128 ↗MalfunctionDec 4, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD¿ THREADED LOCK CANNULA HAD A LOOSE CONNECTION WITH THE MATING COMPONENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "DURING USING THE THREADED LOCK CANNULA IN AN ENDOSCOPY ROOM, THE HCP NOTICED THAT ITS CONNECTION BECAME LOOSE AND THUS STOPPED THE USE."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10945999 ↗MalfunctionDec 1, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD THREADED CANNULA INTERLINK¿ LEAKAGE OCCURRED AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: AFTER USING A THREADED LOCK, THE HCP FOUND FLUID LEAKAGE FROM THE CONNECTION. AFTER DISCOVERING THIS ISSUE, THE HCP ATTEMPTED TO SCREW IT TO THE END BUT FELT LIKE IT WAS PUSHED BACK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10925427 ↗MalfunctionOct 27, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT FLUIDS WOULDN'T DRIP FROM THE BD¿ THREADED LOCK CANNULA WHEN IT WAS CONNECTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "EVEN AFTER CONNECTING TO THE THREADED LOCK CANNULA, FLUIDS DIDN'T DRIP DOWN."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10742620 ↗MalfunctionOct 22, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DIRT WAS FOUND ON THE BD¿ THREADED LOCK CANNULA BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THIS IS A REPORT ABOUT FM (DIRT) FOUND ON THE PRODUCT BEFORE USE."
Patient problems: No Patient Involvement
MAUDE report 10723511 ↗MalfunctionSep 16, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT CANNULA INTERLINK THREADED LOCK COMPONENTS WERE NOT CONNECTED FIRMLY. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN CLINICAL SETTINGS, THE COMPONENTS WERE NOT CONNECTED FIRMLY AND THE CONNECTION WAS LOOSE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10544664 ↗MalfunctionAug 29, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT 5 BD THREADED LOCK CANNULA WERE DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTED: SOME CANNULAS WERE FOUND TO BE SHORT. THE CUSTOMER IS REQUESTING FOR REPLACEMENT BY ANOTHER LOT PRODUCTS."
Patient problems: No Patient Involvement
MAUDE report 10469518 ↗MalfunctionAug 11, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT BD THREADED LOCK CANNULA WAS BROKEN, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BEFORE USE, IT WAS UNABLE TO INSERT THE CANNULA INTO A SYRINGE."
Patient problems: No Patient Involvement
MAUDE report 10394152 ↗MalfunctionAug 5, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 4 BD THREADED LOCK CANNULAS WERE CRACKED/DAMAGED/DEFORMED/BENT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER IS USING THIS PRODUCT ONLY AT NICU. THE THREADED LOCK CANNULA WAS TOO SHORT TO INSERT (SHORT LENGTH). THE CUSTOMER HAS EXPERIENCED THIS INCIDENT SEVERAL TIMES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10370449 ↗MalfunctionJul 16, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD THREADED LOCK CANNULA EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EVEN AFTER CONNECTING TO THE THREADED LOCK, FLUIDS DIDN'T DRIP DOWN. LOT NUMBER IS EITHER 9340414 OR 923673.
Patient problems: No Patient Involvement
MAUDE report 10282844 ↗MalfunctionJul 9, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD¿ THREADED LOCK CANNULA CONNECTION WAS DAMAGED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CANNULA CONNECTION PART WAS DAMAGED."
Patient problems: No Patient Involvement
MAUDE report 10253604 ↗MalfunctionJun 3, 2020Break; Leak/Splash
IT WAS REPORTED THAT CANNULA INTERLINK THREADED LOCK HAD MOLDING DEFECTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CANNULA WAS SHORTER THAN USUAL AND THE RUBBER PART OF THE INJECTION SITE DIDN'T OPEN. HCP COULDN'T FLOW INFUSION.
Patient problems: No Patient Involvement
MAUDE report 10114788 ↗MalfunctionJun 1, 2020Leak/Splash
IT WAS REPORTED THAT THE BD¿ THREADED LOCK CANNULA WAS DAMAGED DURING USE AND WOULDN'T CONNECT WITH THE EXTENSION TUBE. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CANNULA WAS DAMAGED AND HCP COULDN'T CONNECT. LEAKAGE OCCURRED?" "CUSTOMER COMMENTED "IT TURNS AND NEVER STOP WHEN USING WITH (B)(4) AND CONNECTED WITH EX-TUBE" THE ISSUE REPORTED AS ANOTHER COMPLAINT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10106320 ↗MalfunctionMay 28, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT BD THREADED LOCK CANNULA WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A NEEDLE OF THREADED LOCK WAS SHORT AND HCP COULDN'T INJECT EVEN CONNECTED."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10098711 ↗MalfunctionMay 19, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD¿ THREADED LOCK CANNULA WAS "SHORTER THAN USUAL", AND A "RUBBER PART" OF THE INJECTION SITE WOULDN'T OPEN TO LET THE INFUSION FLOW THROUGH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "A CANNULA WAS SHORTER THAN USUAL AND A RUBBER PART OF THE INJECTION SITE DIDN'T OPEN. HCP COULDN'T FLOW INFUSION."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10069941 ↗MalfunctionMay 12, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT BD THREADED LOCK CANNULA LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OCCURRED FROM A INJECTION SITE. CUSTOMER SUSPECTS THE CANNULA PART WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10047973 ↗MalfunctionMay 4, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT THE BD THREADED LOCK CANNULA EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A CANNULA WAS SHORTER THAN USUAL AND THE RUBBER PART OF THE INJECTION SITE DIDN'T OPEN. THE ROUTE WAS OCCLUDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10022178 ↗MalfunctionApr 29, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD THREADED LOCK CANNULA EXPERIENCED LEAKAGE AT THE CONNECTION SITE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALINE LEAKED FROM A CONNECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10012345 ↗MalfunctionApr 20, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TIP OF THE INTERLINK DETACHED WITH A BD THREADED LOCK CANNULA. THIS OCCURRED ON 4 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: INSIDE OF CANNULA WAS DETACHED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9979920 ↗MalfunctionApr 16, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD THREADED LOCK CANNULA HAD A CONNECTOR DEFECT. THIS OCCURRED ON 2 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 THREADED LOCKS TURNED AND NEVER STOPPED. ALSO HCP COULDN'T INJECT TO ANOTHER THREADED LOCK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9970062 ↗MalfunctionMar 30, 2020Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 BD THREADED LOCK CANNULAS WERE CLOGGED/OCCLUDED OR EXPERIENCED FLOW ISSUES. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCTS DIDN'T PASS WATER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9901388 ↗MalfunctionMar 30, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE THE TIP OF INTERLINK BREAKS OFF WITH A BD THREADED LOCK CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: A NEEDLE WAS BROKEN AND HCP COULDN'T CONNECT IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9900899 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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