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

Catalog Number 309623

Device Problems Melted (1385); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ tb syringe with bd precision glide¿ detachable needle had a deformed stopper.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.: 309623, batch/lot: 8294989.It was reported that the customer found "some of this lot number have a melted plunger''.Is reporting an issue with some bd syringes, part number 309623, lot number 8294989.It is reported that they found some of this lot number have a ¿melted plunger¿.This occurred in the pharmacy- as the plunger was pulled back, it pulled the rubber, sticking down the side of the syringe.

Manufacturer Narrative

H.6.Investigation: 27 sealed packaged 1ml s/t syringes and 1 opened packaged 1ml s/t syringe were received, confirmed to be form batch #8294989 (p/n 309623).They were visually evaluated.The 1 syringe in the opened package had a jammed stopper condition.No defects were found in the 27 sealed packaged syringes.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Potential root cause for the jammed stopper defect is associated with the assembly process.

Event Description

It was reported that bd¿ tb syringe with bd precisionglide¿ detachable needle had a deformed stopper.This occurred on 2 separate occasions.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: ¿material no.: 309623.Batch/lot: 8294989.It was reported that the customer found "some of this lot number have a melted plunger." is reporting an issue with some bd syringes, part number 309623, lot number 8294989.It is reported that they found some of this lot number have a ¿melted plunger.¿ this occurred in the pharmacy-as the plunger was pulled back, it pulled the rubber, sticking down the side of the syringe.".

• Brand Name: BD TB SYRINGE WITH BD PRECISIONGLIDE DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8464966
• MDR Text Key: 145639622
• Report Number: 1213809-2019-00388
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096238
• UDI-Public: 30382903096238
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 309623
• Device Lot Number: 8294989
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other