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	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 10ml ll wwd had blurred scale printing.The following information was provided by the initial reporter: "during mfg process at togo medikit, blur printing 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 one major and two minor grad lines partially missing between the 1ml and 2ml markings.Two of the grad lines were missing more then 50%, which was rejectable per product specification.A potential root cause for the missing scale defect is associated with the marking process.Unfortunately, the batch/lot information is required to make corrective action determinations.No corrective actions are necessary at this time.H3 other text: see h.10.
Event or Problem Description
It was reported that syringe 10ml ll wwd had blurred scale printing.The following information was provided by the initial reporter: "during mfg process at togo medikit, blur printing 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: 10117357
• Report Number: 1213809-2020-00370
• Device Sequence Number: 16679880
• 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