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

Catalog Number	301997
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: one photo was received and evaluated.The photo depicted a single strip of 10ml packages visible from the top web side, confirmed to be from batch #8323956 (b)(4).The packages had no visible perforation between them, which is a rejectable condition per product specification.Investigation conclusion: 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.Root cause description: 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.Rationale: the packaging machine involved with producing this product is no longer in service, therefore no corrective action are necessary.
Event or Problem Description
It was reported that syringe 10ml ll wwd had poor perforation.This occurred on 27 occasions.The following information was provided by the initial reporter: material no: 301997, batch no: 8323956.  it was reported that experiencing usage difficulty   event description states: we have 24 uncontaminated syringes on hand and the problem is that there are no dotted areas to separate them.As scissors must be used to separate them, this compromises the sterilization of the item.

• Brand Name: SYRINGE 10ML LL WWD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11083716
• Report Number: 1213809-2020-00921
• Device Sequence Number: 3207471
• Product Code: FMF
• UDI-Device Identifier: 00382903019977
• UDI-Public: 00382903019977
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 301997
• Device Lot Number: 8323956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1