MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE; SYRINGE AND NEEDLE

Catalog Number 305270

Device Problems Unintended Ejection (1234); Leak/Splash (1354); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.(b)(4).Device evaluation: a sample has been returned for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the suspect device was being used to given a vaccination.The vaccine leaked out around the hub of the needle rather than injecting into the patient.When the technician pushed the button to retract the needle, the needle failed to retract and it ejected from the syringe.No injuries occurred as a result of this incident.

Manufacturer Narrative

Device evaluation: result - the complaint handling lab received three (3) bd integra syringes.Two (2) sealed and one (1) used bd 25 gaxin integra syringe with needle cat# 305270 lot# 4322824.The two (2) sealed samples were visually inspected no defects were observed.The samples were activated following the step in the ifu and the needles of both samples retracted without an issue.After the medication is completely administered you are to push the plunger rod until you hear two (2) ¿clicks." if you depress the plunger rod and do not hear the ¿clicks¿ the safety mechanism will not activate and the needle will not retract.For the one (1) sample that was returned used, the needle was not attached to the syringe.The plunger rod was fully depressed and the retraction mechanism was activated and the needle (that was not attached to the syringe) was not retracted.This confirms the customer¿s issue of the needle not being retracted and being ejected.In respect to the leakage issue, when a needle does not retract there will be leakage because the fluid in the barrel will escaped through the hole the needle was supposed to retract into.The reported lot# 4322824 was produced in nov 2014.A review of the device history record was performed, no machine adjustments were noted and all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.This lot was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Conclusion - bd was able to confirm the customer's indicated failure.An absolute root cause was not determined.

• Brand Name: 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6133403
• MDR Text Key: 61302789
• Report Number: 1213809-2016-00045
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 305270
• Device Lot Number: 4322824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other