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

Model Number	301997
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/07/2020
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.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that syringe 10ml ll wwd was damaged, but still operable.The following information was provided by the initial reporter: "during mfg process, dent barrel product was confirmed.".
Additional Manufacturer Narrative
H.6.Investigation: two photos and one loose 10ml syringe was received and evaluated.It was observed there was a small indentation present outside the grad lines slightly above the 10ml marking.The indentation appeared to be cosmetic in nature with no effect to form fit or function of the device, which was acceptable per product specification.Based on the verbatim, it was reported to be found during the manufacture of an outside process.Additionally based on the size and shape of the small deformation, the defect could not be confirmed to originate from internal manufacturing as more significant damage would be likely to have occurred.The potential root cause for the slightly damaged barrel could not be confirmed as an outside manufacturing process was involved.H3 other text : see h.10.
Event or Problem Description
It was reported that syringe 10ml ll wwd was damaged, but still operable.The following information was provided by the initial reporter: "during mfg process, dent barrel product was confirmed.".

• 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: 10117358
• Report Number: 1213809-2020-00369
• Device Sequence Number: 2142480
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 06/23/2020

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 Model Number: 301997
• Device Catalogue Number: 301997
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/24/2020
• 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