MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP; PISTON SYRINGE

Catalog Number 309657

Device Problems Break (1069); Crack (1135)

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

Event Date 04/08/2019

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 after opening the packaging, the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip plunger rod was found cracked/broken.The following information was provided by the initial reporter: "when opening wrapping, noticed plunger is cracked/broken.Not used on patient.".

Event Description

It was reported that after opening the packaging, the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip plunger rod was found cracked broken.The following information was provided by the initial reporter: "when opening wrapping, noticed plunger is cracked/broken.Not used on patient.".

Manufacturer Narrative

H.6.Investigation: one 3ml syringe in an opened package from batch #8335843 (p/n 309657) was received and visually evaluated.The plunger rod was observed to have a cracked rib.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 broken plunger rod defect is associated with the assembly process.

• Brand Name: BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8549672
• MDR Text Key: 145786614
• Report Number: 1213809-2019-00474
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 309657
• Device Lot Number: 8335843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other