MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LL SP125; PISTON SYRINGE

Catalog Number 309646

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 5ml ll sp125 had poor perforation on the packaging.This occurred on 15 occasion.The following information was provided by the initial reporter: material no: 309646, batch no: 9337381.It was reported that the packaging is not perforated so the customer cannot open without tearing the next one attached and ruining sterility.

Manufacturer Narrative

H.6.Investigation: fifteen blister packs in strips of three from batch 9337381 (p/n 309646) were received and evaluated.Thirteen were fully sealed with a syringe inside and two were opened and empty.It was observed there was no perforation between the blister packs in the strips, which was rejectable per product specification.Potential root cause for the uncut package defect is associated with the packaging process.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.H3 other text : see h.10.

Event Description

It was reported that syringe 5ml ll sp125 had poor perforation on the packaging.This occurred on 15 occasion.The following information was provided by the initial reporter: material no: 309646 batch no: 9337381.It was reported that the packaging is not perforated so the customer cannot open without tearing the next one attached and ruining sterility.

• Brand Name: SYRINGE 5ML LL SP125
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11163241
• MDR Text Key: 227950704
• Report Number: 1213809-2021-00015
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096466
• UDI-Public: 00382903096466
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309646
• Device Lot Number: 9337381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1