BD Integra 305273Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903052738), received between Aug 17, 2018 and May 24, 2023 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2023Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED WHILE USING BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 21 G X 1 IN., 3 ML THE NEEDLE RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WAS DEFECTIVE. CUSTOMER DREW UP THE MEDICATION, WHEN CUSTOMER'S WIFE WENT TO ADMINISTER MEDICATION IN LEFT BUTTOX THEY HEARD A POP. NEEDLE HAD BROKE OFF IN CUSTOMER. THERE WAS A LOT OF BLOOD. CUSTOMER WENT TO ER, ULTRASOUND DID NOT LOCATE NEEDLE. AT ER THEY DID SMALL INCISION AND ATTEMPTED TO LOCATE NEEDLE WITH TWEEZERS WITH NO LUCK. WENT TO OR NEXT DAY AND DID PRE-OPERATION X-RAY AND COULD NOT LOCATE NEEDLE. SURGEON SEWED UP INCISION AND TOOK APART THE DEFECTIVE SYRINGE. UPON TAKING APART THE SYRINGE IT WAS FOUND THAT THE NEEDLE HAD RETRACTED INTO THE SYRINGE. CUSTOMER WAS GIVEN A STITCH FOR THE INCISION AND PRESCRIBED ANTIBIOTICS AS A RESULT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17000026 ↗
• MalfunctionMar 31, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW WAS NOT RETRACTING. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE NOT RETRACTING. REPORTED ISSUE - SYRINGE NOT RETRACTING. SOME VAGUE AND CONFLICTING INFORMATION HAS BEEN PROVIDED. WILL PROVIDE MORE DETAILS WHEN MORE INFORMATION PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599557 ↗
• MalfunctionMar 11, 2021Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW NEEDLE RETRACTION PREMATURELY. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE RETRACTED PREMATURELY. NEEDLE RETRACTED SPONTANEOUSLY WHILE ADMINISTERING MEDICATION MEANING THAT NOT ALL OF THE MEDICATION COULD BE ADMINISTERED. HAS HAPPENED ON SEVERAL OCCASIONS OVER THE LAST COUPLE OF WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11468241 ↗
• InjuryJul 6, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE SYRINGE INTEGRA 3ML W/NDL 21X1 RB TW EXPERIENCED NEEDLE RETRACTION FAILURE AND WAS INVOLVED WITH A SIRTY NEEDLE STICK INJURY. IT HAS BEEN MENTIONED THAT THE NURSE WHO RECEIVED THE DIRTY NEEDLE STICK INJURY RECEIVED MEDICAL INTERVENTION AS A RESULT, THOUGH THE SPECIFIC INTERVENTION OR ANY ASSOCIATED TESTING RESULTS HAVE NOT BEEN SPECIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305273, BATCH NO: 8095530. CUSTOMER CALLED TO REPORT THAT NEEDLE DID NOT RETRACT CAUSING THE NURSE TO GET STUCK WITH THE NEEDLE AFTER INJECTION. SHE STATED THAT THE NURSE WAS SENT OUT PER PROTOCOL TO MEDICAL FACILITY, IT HAPPENED LAST NIGHT AND EMPLOYEE HEALTH WAS NOT OPEN AT THAT TIME.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 10237811 ↗
• MalfunctionAug 17, 2018Retraction Problem

  IT WAS REPORTED WITH THE USE OF THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE THERE WAS AN ISSUE WITH SPRING FAILURE. WHEN THE NEEDLE RETRACTED, THE SPRING DID NOT RETRACT INTO THE PLUNGER. INSTEAD, IT CURLED UP IN THE SYRINGE, BETWEEN THE HUB AND PLUNGER. COULD NOT SEE THE NEEDLE IN THE SYRINGE, OR ANYWHERE SO THE PATIENT WAS GIVEN A X-RAY TO DETERMINE IF IT WAS LODGED IN THE PATIENT. IT WAS NEGATIVE AND THE NEEDLE WAS FOUND IN THE PLUNGER OF THE SYRINGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7794931 ↗