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

Model Number	301997
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use it was discovered that the packages have poor perforation with a bd syringe 10ml ll wwd.The following information was provided by the initial reporter: it was reported that the syringes are not pre-cut as usual, making it impossible to use because the packaging tears.
Additional Manufacturer Narrative
H.6.Investigation: one photo was received and evaluated.The photo depicted a strip of five 10ml packages, confirmed to be from batch #8323956 (p/n 301997), cavities 6-10.There was no visible perforation between the packages.Machine logs indicate there was issues with the slitters during the manufacture of this batch.Adjustments were made to fix the slitter during the manufacture of this batch.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.Potential root cause for the poor perforation defect is associated with the packaging process.It was likely due to an issue with the slitter not functioning properly.No corrective actions are necessary based on the defective rate identified.Batch 8323956 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that during use it was discovered that the packages have poor perforation with a bd syringe 10ml ll wwd.The following information was provided by the initial reporter: it was reported that the syringes are not pre-cut as usual, making it impossible to use because the packaging tears.

• Brand Name: BD 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: 9751411
• Report Number: 1213809-2020-00137
• Device Sequence Number: 14183304
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: 8323956
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other