MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL WWD; PISTON SYRINGE

Model Number 301997

Device Problem Packaging Problem (3007)

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

Event Date 12/06/2019

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 a packing error occurred before use with a syringe 10ml ll wwd.The following information was provided by the initial reporter, "the packages are not separable.The pack of 5 syringes cannot be separated.".

Manufacturer Narrative

H.6.Investigation summary: one strip of five 10ml syringes in fully sealed blister packs from batch 8323956 (p/n 301997) were received and evaluated.It was observed there was no perforation between blister packs, which was rejectable per product specification.Machine logs indicate there was issues with the slitters during the manufacture of this batch.Potential root cause for the poor perforation defect is associated with the packaging process.It was likely due to and issue with the slitter not functioning properly.The packaging machine involved is no longer in use.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that a packing error occurred before use with a syringe 10ml ll wwd.The following information was provided by the initial reporter, "the packages are not separable.The pack of 5 syringes cannot be separated.".

• Brand Name: SYRINGE 10ML LL WWD
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9527661
• MDR Text Key: 193668555
• Report Number: 1213809-2019-01312
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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 Expiration Date: 10/31/2023
• Device Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: 8323956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other