MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK¿ SYRINGE

Catalog Number 300771

Device Problem Material Twisted/Bent (2981)

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

Event Date 12/25/2018

Event Type  malfunction  

Manufacturer Narrative

Report source other: local monitoring authority.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 luer-lok¿ syringe needle hub is bent.This occurred on 20 separate occasions but the date/time and or patient information is unknown.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: one photo was received and evaluated.The photo observed the needle assembled was tilted.Based on the dhr review, there were no rejects related to the reported defect condition for the assembled needle during inspection.Unable to confirm the nonconformance as samples were not returned for evaluation.Therefore, root cause could not determined.

Event Description

It was reported that bd luer-lok¿ syringe needle hub is bent.This occurred on 20 separate occasions but the date/ time and or patient information is unknown.No serious injury or medical intervention was reported.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8236484
• MDR Text Key: 132781626
• Report Number: 8041187-2018-00525
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 300771
• Device Lot Number: 8081117
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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
• Patient Outcome(s): Other