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

Catalog Number 302995

Device Problem Crack (1135)

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

Event Date 09/01/2018

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 during use of the bd syringe luer-lok¿ tip the syringe was cracked.

Manufacturer Narrative

Investigation summary: one loose 10ml syringe and one opened package, confirmed to be from batch #8158756 (p/n 302995), were received.The sample was visually evaluated.The sample had a label attached and appeared used with liquid residue inside, therefore evaluation was performed through the sample bag.A small scratch approximately 1/2¿ long was observed at the level of 1ml outside the scale markings.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.It is possible the observed scratch was the crack reported by the customer, although it could not be definitively confirmed.Potential root cause for the scratch/crack is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.

Event Description

It was reported that during use of the bd syringe luer-lok¿ tip the syringe was cracked.

• Brand Name: BD SYRINGE 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: 8191271
• MDR Text Key: 131340061
• Report Number: 1213809-2018-00932
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903029953
• UDI-Public: 30382903029953
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 302995
• Device Lot Number: 8158756
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other