MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD; PISTON SYRINGE

Model Number	329410
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used.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 5 syringe 1.0ml 28ga 1/2in 10bag 500 bdd were damaged before use.The following was reported by the initial reporter: "it was reported that the syringes were damaged.Verbatim: hello, i need to report a damaged & refused on a recent po.".
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
Event or Problem Description
It was reported that 5 syringe 1.0ml 28ga 1/2in 10bag 500 bdd were damaged before use.The following was reported by the initial reporter: "it was reported that the syringes were damaged verbatim: hello, i need to report a damaged & refused on a recent po.".

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN 10BAG 500 BDD
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10831824
• Report Number: 2243072-2020-01812
• Device Sequence Number: 3043439
• Product Code: FMF
• UDI-Device Identifier: 30382903294108
• UDI-Public: 30382903294108
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 329410
• Device Catalogue Number: 329410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1