MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928856
Medical Device Problem Codes	Break (1069); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 pl/wg cannula broke off and was used after expiration.The following information was provided by the initial reporter: "consumer reported found needles break at the tip in his thigh injections from this box.Used tweezers to remove.No medical attention received.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/19/2020.H.6.Investigation: customer returned (6) 1cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 4349704.Customer states that the needle break at the tip.All returned syringes were examined and no broken cannula was observed.Also, this product was manufactured in february 2015 and has a shelf life of 5 years, indicating that this product expired in february 2020.A review of the device history record was completed for batch# 4349704.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to complaint.This product was made in 2015, therefore it would be expired.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 pl/wg cannula broke off and was used after expiration.The following information was provided by the initial reporter: "consumer reported found needles break at the tip in his thigh injections from this box.Used tweezers to remove.No medical attention received.".

• Brand Name: SYRINGE 1.0ML 31GA 8MM 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: 10093693
• Report Number: 1920898-2020-00574
• Device Sequence Number: 19496443
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: Other
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 4349704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/08/2020
• 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