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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
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 syringe 1.0ml 31ga 8mm 10bag 500 wal cannula broke off.The following information was provided by the initial reporter: material no.328506 batch no.0904205.It was reported that needle broke off in vial while drawing up insulin.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-04-05.Investigation summary: customer returned a single syringe in a pouch labeled for 1ml, 31 gauge, 8mm syringes from lot 0090428.The syringe needle is broken and jagged with the breakage close to the barrel of the syringe.Torquing the syringe and thus needle to one side may have resulted in the needle butting up against the wall of the vial.High stresses could be significant enough for it to fracture.A review of the device history record was completed for batch# 0090428.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, bd was able to confirm the customer¿s indicated failure of the needle breaking.The root cause of the needle breaking may be accidentally torquing the syringe while inside of an associated vial, placing sufficient stress on the needle to break it.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 wal cannula broke off.The following information was provided by the initial reporter: material no.328506, batch no.0904205.It was reported that needle broke off in vial while drawing up insulin.

• 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: 11490227
• Report Number: 1920898-2021-00293
• Device Sequence Number: 4101662
• 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
• 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): 04/06/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1