MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK DISPOSABLE SYRINGE

Catalog Number 309628

Device Problem Difficult to Remove (1528)

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

Event Date 02/06/2019

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 luer-lok¿ disposable syringe needle cannot be manually removed from the syringe.No serious injury or medical intervention was reported.

Event Description

It was reported that bd luer-lok¿ disposable syringe needle cannot be manually removed from the syringe.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: one loose 1ml syringe with needle attached was received and evaluated.It was observed most of the grad lines were worn off and the plunger rod was removed.The needle was untwisted from the syringe manually with little difficulty.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.Root cause not defined since defects were not confirmed in sample received.No corrective actions recommended since product defect was not confirmed.

• Brand Name: BD LUER-LOK DISPOSABLE SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8374449
• MDR Text Key: 137557655
• Report Number: 1213809-2019-00288
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096283
• UDI-Public: 30382903096283
• Combination Product (y/n): N
• PMA/PMN Number: K941562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 309628
• Device Lot Number: 7240898
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other