MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG

Model Number	323001
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 vet syringe 0.5ml x 29g x 12.7mm 10 bag needle went through the shield and caused a needlestick injury.This was discovered during use.The following information was provided by the initial reporter: material no.323001 ; batch no.9126619.It was reported that needle went through the shield as he was re-shielding and the customer was stuck by the needle as he was holding the shield.Event description via phone call states: pet owner reported that the needle went through the shield as he was re-shielding.Consumer's finger was stuck by the needle as he was holding the shield, no injury, no medical assistance.
Event or Problem Description
It was reported that vet syringe 0.5ml x 29g x 12.7mm 10 bag needle went through the shield and caused a needlestick injury.This was discovered during use.The following information was provided by the initial reporter: material no.323001 batch no.9126619.It was reported that needle went through the shield as he was re-shielding and the customer was stuck by the needle as he was holding the shield.Event description via phone call states: pet owner reported that the needle went through the shield as he was re-shielding.Consumer's finger was stuck by the needle as he was holding the shield, no injury, no medical assistance.
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: 10/1/2020.H.6.Investigation: customer returned four (4) 29gx12.7mm, 0.5ml bd insulin syringes from an open polybag from lot 9126619.Consumer reported that the needle went through the shield as he was re-shielding.All 4 returned syringes were examined, and it was observed that 1 syringe exhibited a cannula through the cannula shield.No evidence of manufacturing defect was observed.Since all 4 syringes were returned after use, and no manufacturing defects were observed, the probable cause of the cannula through the shield is user error: if the user removes or reattaches the cannula shield obliquely they may bend the cannula and potentially cause the cannula to pierce the shield when reattaching the cannula shield.A review of the device history record was completed for batch# 9252463.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200827666, 200821592] noted that did not pertain to the complaint.

• Brand Name: VET SYRINGE 0.5ML X 29G X 12.7MM 10 BAG
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10614412
• Report Number: 1920898-2020-01339
• Device Sequence Number: 1178725
• Product Code: FMF
• UDI-Device Identifier: 00382903230013
• UDI-Public: 00382903230013
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 323001
• Device Catalogue Number: 323001
• Device Lot Number: 9126619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/15/2020
• 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