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

Model Number	301997
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that syringe 10ml ll wwd plunger rod was damaged.This was discovered before use.The following information was provided by the initial reporter: before use, the customer found a damage on the plunger rod.It was sharp and dangerous.
Event or Problem Description
It was reported that syringe 10ml ll wwd plunger rod was damaged.This was discovered before use.The following information was provided by the initial reporter: before use, the customer found a damage on the plunger rod.It was sharp and dangerous.
Additional Manufacturer Narrative
H.6.Investigation: five photos and one loose 10ml syringe were received and evaluated.It was observed there was a significant indentation in the barrel near the 9ml marking.The plunger rod was also damaged in the same location with a portion of the thumb rest broken off.The damage was rejectable per product specification.The potential root cause for the damaged barrel /plunger rod defect is associated with the assembly process.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see h.10.

• 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: 10590948
• Report Number: 1213809-2020-00663
• Device Sequence Number: 16787128
• Product Code: FMF
• UDI-Device Identifier: 30382903019978
• UDI-Public: 30382903019978
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/09/2020

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: 09/16/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 09/26/2020
• Supplement Report FDA Received Date: 10/09/2020
• 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