MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928851
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that one bag of (10) syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg had an expired expiration date before use.The following was reported by the initial reporter: "it was reported that bag is expired and damaged.Verbatim: consumer reported just purchase a bag that is expired.The bag is damaged looking too".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-23.H6: investigation summary customer returned one (1) unused 29gx12.7mm, 0.5ml insulin syringe polybag from lot 5349771.Consumer reported just purchase a bag that is expired, and the bag is damaged looking too.The returned polybag was examined, and it was observed that the returned samples were not expired, and the polybag was not damaged.Samples from lot 5349771 were manufactured in january 2016 with a 5 year shelf life, therefore, the samples would expire in january 2021.No evidence of manufacturing defect was observed.Since no defects were observed, the alleged issues could not be confirmed.A review of the device history record was completed for batch# 5349771.All inspections and challenges were performed per the applicable operations qc specifications.There were one (1) notification [(b)(6)] noted that did not pertain to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that one bag of (10) syringe 0.5ml 29ga 1/2in 10bag 500 pl/wg had an expired expiration date before use.The following was reported by the initial reporter: "it was reported that bag is expired and damaged.Verbatim: consumer reported just purchase a bag that is expired.The bag is damaged looking too".

• Brand Name: SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10681761
• Report Number: 1920898-2020-01404
• Device Sequence Number: 19697020
• Product Code: FMF
• UDI-Device Identifier: 00311917014890
• UDI-Public: 00311917014890
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: Lay User/Patient
• Device Model Number: 928851
• Device Catalogue Number: 928851
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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