MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 12.7MM 10BAG 500 WAL; PISTON SYRINGE

Model Number	328507
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is (b)(6) has been used as a default.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Event or Problem Description
It was reported that a box of syringe 0.5ml 29ga 12.7mm 10bag 500 wal had missing label information during use.The following wa sreported by the initial reporter: "it was reported that the wife of a consumer wanted to know the expiration date for a box her husband may have used.Verbatim: spouse of relion consumer wanted to know expiration date for syringes she thinks her husband may have used.Could not say for sure.Stated, she was cleaning out her closet and came across the syringes lot: 1031309, catalog: 328507, trademark: unknown, date of event: na, samples: na.Will not be sending letter, mail kit, or replacement for this file.".

• Brand Name: SYRINGE 0.5ML 29GA 12.7MM 10BAG 500 WAL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11580198
• Report Number: 1920898-2021-00357
• Device Sequence Number: 11836421
• Product Code: FMF
• UDI-Device Identifier: 00681131311649
• UDI-Public: 00681131311649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2021

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: Lay User/Patient
• Device Model Number: 328507
• Device Catalogue Number: 328507
• Device Lot Number: 1031309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1