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

Model Number	301997
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that the syringe 10ml ll wwd barrel was damaged and the plunger rod was broken.The following information was provided by the initial reporter, translated from (b)(6) to english: "before use, the customer found that the barrel was damaged and the plunger rod was broken.".
Event or Problem Description
It was reported that the syringe 10ml ll wwd barrel was damaged and the plunger rod was broken.The following information was provided by the initial reporter, translated from japanese to english: "before use, the customer found that the barrel was damaged and the plunger rod was broken.".
Additional Manufacturer Narrative
H.6.Investigation: samples and photos received for investigation.Six photos appearing to display the same loose 10ml syringe with needle attached were received and evaluated.It was observed in each of the photos, the plunger rod had a large crack present in one of the ribs starting approximately 1" above the retaining ring and extending near the underside of the thumb rest.A portion of the broken rib was protruding outwards.There was also some barrel deformation near the 10ml marking area, which was consistent where the plunger rod was damaged.The damage was rejectable per product specification.Potential root cause for the damaged barrel and plunger rod defect is associated with the assembly process.Dhr could not be performed due to unknown lot#.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: 10988662
• Report Number: 1213809-2020-00885
• Device Sequence Number: 10950758
• 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: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 11/25/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1