MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE¿ LUER SLIP WITH NEEDLE; PISTON SYRINGE

Catalog Number 300841

Device Problem Material Separation (1562)

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

Event Date 12/18/2018

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 the bd syringe¿ luer slip with needle stopper "separated from plunger" during use.

Manufacturer Narrative

Investigation summary: one photo was received for investigation which showed two syringe products.Stopper separation from plunger could be observed.Based on the dhr review no abnormality during production.Investigation conclusion: stopper separation from plunger could be observed in the returned photo.Root cause description: the complaint could not be confirmed and root cause could not be determined without an actual sample for evaluation.Rationale: if samples are received in the future the complaint will be re-open and re-investigated.

Event Description

It was reported that the bd syringe¿ luer slip with needle stopper "separated from plunger" during use.

• Brand Name: BD SYRINGE¿ LUER SLIP WITH NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8227648
• MDR Text Key: 132493565
• Report Number: 8041187-2018-00522
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 300841
• Device Lot Number: 8141111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other