MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 1ML ULTRA FINE INSULIN SYRINGE; PISTON SYRINGE

Model Number	329410
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: 8241181 was reported, however, that is not a manufactured lot# for this product line.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: unable to perform complaint lot history check for label information missing (expiration date) due to unknown lot number.No samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Unable to perform dhr check for label information missing (expiration date) due to unknown lot number.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that the box label information is missing with a bd 1ml ultra fine¿ insulin syringe.The following information was provided by the initial reporter: it was reported that there is no expiration date or copyright date on any of the boxes.

• Brand Name: BD 1ML ULTRA FINE INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10019324
• Report Number: 1920898-2020-00455
• Device Sequence Number: 14423485
• Product Code: FMF
• UDI-Device Identifier: 30382903294108
• UDI-Public: 30382903294108
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2020

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: Health Professional
• Device Model Number: 329410
• Device Catalogue Number: 329410
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/01/2020
• 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