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 Patient Involvement (2645)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that one bd¿ syringe 10ml ll wwd has been found experiencing poor perforation before use.The following has been provided by the initial reporter: it was reported there were no dotted lines between the 10cc sterile syringes resulting in loss of time because it requires scissors to separate them.
Event or Problem Description
It has been reported that one bd¿ syringe 10ml ll wwd has been found experiencing poor perforation before use.The following has been provided by the initial reporter: it was reported there were no dotted lines between the 10cc sterile syringes resulting in loss of time because it requires scissors to separate them.
Additional Manufacturer Narrative
H.6.Investigation: three 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 the blister packs, which was rejectable per product specification.Potential root cause for the no perforation defect is associated with the packaging process.The machine associated with this defect has been decommissioned as of (b)(6) 2018.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.

• 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: 9540438
• Report Number: 1213809-2019-01329
• Device Sequence Number: 14142280
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/02/2020
• Supplement Report FDA Received Date: 02/26/2020
• 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