MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE 21 1-1/4 TW BULK PACK; SYRINGE

Catalog Number 8081779

Device Problem Material Separation (1562)

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

Event Date 01/11/2019

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 180,000 needle 21 1-1/4 tw bulk pack experienced needle cap separation.

Manufacturer Narrative

Investigation: sample was not decontaminated by vendor.41 samples with no packaging was returned for evaluation.It was observed that loose shield can be seen in the returned package.The internal diameter of the shield was subjected to snap fit diameter test as per shield molding 60005301 test procedure.The results of the test show that samples had fail the test.Loose shield could have probably caused by a shield deformation.The manufacturing process was reviewed.It was suspected that the hot core may have cause the bubbling tube to be dented.This may result in the water flow not sufficient which may result in the shield not properly formed.Review of dhr revealed all required challenges and testing was performed as per specification and there were no reject activity findings throughout the build of this lot that would impact the quality of the product.

Event Description

It was reported that 180,000 needle 21 1-1/4 tw bulk pack experienced needle cap separation.

• Brand Name: NEEDLE 21 1-1/4 TW BULK PACK
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8302538
• MDR Text Key: 134973917
• Report Number: 8041187-2019-00128
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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 Catalogue Number: 8081779
• Device Lot Number: 8302568
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other