MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number 305271

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger of the bd integra¿ syringe with detachable needle ruptured through the black gasket on the bottom of the plunger and the medication leaked out.The following information was provided by the initial reporter: the plunger ruptured through the black gasket on the bottom of the plunger and the medication leaked out.

Event Description

It was reported that the plunger of the bd integra¿ syringe with detachable needle ruptured through the black gasket on the bottom of the plunger and the medication leaked out.The following information was provided by the initial reporter: the plunger ruptured through the black gasket on the bottom of the plunger and the medication leaked out.

Manufacturer Narrative

H.6.Investigation: one loose 3ml integra syringe (p/n 305271) was received and evaluated.The syringe was disassembled, the plunger rod was activated and its needle was still attached to the hub.The condition observed is non-conforming per product specification.Potential root cause for the plunger rod defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 0148583 is considered in compliance with our product specification requirements.A device history record review was completed for provided lot number 0148583.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14631771
• MDR Text Key: 293618102
• Report Number: 1213809-2022-00323
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 0148583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1