MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG

Model Number	323000
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 0.3ml x 29g x 12.7mm 10 bag was unable to aspirate.This was discovered during use.The following information was provided by the initial reporter: material no:323000 batch no: 9266921.It was reported that the consumer, a pet owner, feels the plunger is unable to draw up vetsulin.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation?: yes d.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: customer returned (7) 3/10cc, 12.7mm, 29g u40 insulin pet syringes in an open poly bag from lot # 9266921.Customer states that the plunger is unable to draw.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch # 9266921 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200879125] 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 vet syringe 0.3ml x 29g x 12.7mm 10 bag was unable to aspirate.This was discovered during use.The following information was provided by the initial reporter: material no:(b)(4)batch no: 9266921 it was reported that the consumer, a pet owner, feels the plunger is unable to draw up vetsulin.

• Brand Name: VET SYRINGE 0.3ML 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: 10505524
• Report Number: 1920898-2020-01168
• Device Sequence Number: 3110766
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/21/2020

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 Expiration Date: 10/31/2024
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 9266921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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