MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5ML 31GX6MM U-100 INSULIN SYRINGE; PISTON SYRINGE

Model Number	328520
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported 0.5ml 31gx6mm u-100 insulin syringe did not have an expiry on its label.The following information was provided by the initial reporter: "consumer reported this box and packets inside do not have expiry dates.Just purchased at store today".
Event or Problem Description
It was reported 0.5ml 31gx6mm u-100 insulin syringe did not have an expiry on its label.The following information was provided by the initial reporter: "consumer reported this box and packets inside do not have expiry dates.Just purchased at store today".
Additional Manufacturer Narrative
The following fields were updated due to corrected information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10/4/2021 h.6.Investigation: customer returned (20) 0.5ml insulin syringes, 2 open polybags, and a portion of a shelf carton from lot# 0027335.The consumer reported that this box and packets inside do not have expiry dates.All returned samples were examined, and it was observed that the expiration dates were not printed on either the polybags or shelf carton.As per manufacturing, lot# 0027335 was produced before expiration dates were printed on packaging.The returned samples fell within specification, therefore, a manufacturing defect could not be confirmed.A review of the device history record was completed for batch# 0027335.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.This was manufactured prior to expiration dates on packaging.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: 0.5ML 31GX6MM U-100 INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12594964
• Report Number: 1920898-2021-01050
• Device Sequence Number: 1547818
• Product Code: FMI
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 0027335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1