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

Model Number	328506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 wal needle broke off before use.The following information was provided by the initial reporter: material no:328506, batch no: 0027941.Verbatim: spouse of relion consumer reported on syringe had the needle break off before the injection.Stated the consumer filled the syringe with her insulin and then the end of the needle tip broke off.Spouse stated consumer did not use the syringe and the syringe is still filled with medication.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 wal needle broke off before use.The following information was provided by the initial reporter: material no:328506, batch no: 0027941.Verbatim: spouse of relion consumer reported on syringe had the needle break off before the injection.Stated the consumer filled the syringe with her insulin and then the end of the needle tip broke off.Spouse stated consumer did not use the syringe and the syringe is still filled with medication.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-18.H6: investigation summary.Customer returned (1) 1cc, 8mm, 31g relion syringe in an open poly bag from lot # 0027941.Customer states that they filled the syringe with her insulin and then the end of the needle tip broke off.The syringe was returned with approximately 16 units of a cloudy liquid in the barrel.The syringe was examined and exhibited a broken cannula.A review of the device history record was completed for batch# 0027941.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Bd was able to confirm the customer¿s indicated failure.Root cause is bending/re-straightening of the cannula by the customer during use of the product.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 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: 10907674
• Report Number: 1920898-2020-01638
• Device Sequence Number: 791251
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (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): 01/13/2021

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: Lay User/Patient
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 0027941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1