MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB; PISTON SYRINGE

Model Number	305500
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that 5 syringe allergy 1ml w/ndl 28x1/2 rb experienced device damage/deformation while still considered oeprable.The following information was provided by the initial reporter: material no: 305500, batch no: unknown.I need to report a damaged & refused receipt.Bd allergy syringe 28g 1/2" 100 305500 upc: 38290550003.Ordered 15, received 15, damaged & refused 5.
Event or Problem Description
It was reported that 5 syringe allergy 1ml w/ndl 28x1/2 rb experienced device damage/deformation while still considered oeprable.The following information was provided by the initial reporter: material no: 305500.I need to report a damaged & refused receipt.Bd allergy syringe 28g 1/2" 100 305500 upc: 38290550003.Ordered 15.Received 15.Damaged & refused 5.
Additional Manufacturer Narrative
H.6.Investigation: since no samples (including photos) were returned for the reported issue of ¿syringes were damaged¿, with reported unknown lot # regarding item # 305500, the complaint could not be confirmed, and the root cause is undetermined.Due to batch number being unknown, no dhr review can be completed.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h.10.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 28X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10832474
• Report Number: 1920898-2020-01553
• Device Sequence Number: 2559119
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K980580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 305500
• Device Catalogue Number: 305500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1