MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML VET U40 29GA 12.7MM 10BAG

Model Number	323000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 0.3ml vet u40 29ga 12.7mm 10bag experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no:323000 batch no: 0174596.Pet owner reported needles crooked/bent.Inconsistent needle color, stated that some of the needles appear to have a dull rather than shiny.Some of the syringes have tiny cracks on barrel towards the top.Consumer does not re-use.
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: 6/16/2021.H.6.Investigation: customer returned (11) loose 3/10cc, 12.7mm vet syringes.Customer states that the needles are crooked/bent, needle color is not consistent and syringes have tiny cracks on the barrel towards the top.All returned syringes were examined and all exhibited a bent cannula.All returned syringes were examined and no discoloration of the cannula was observed on any of the returned syringes.All returned syringes were examined and 5 out of 11 samples exhibited scratched barrels.A review of the device history record was completed for batch # 0174596 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause is user related.The cannula bent during use of the product by the customer.L2l was dispatched for scratches on the barrel coming from the barrel bowl.The barrels were jamming at the infeed when transferring from the bowl.
Event or Problem Description
It was reported that the syringe 0.3ml vet u40 29ga 12.7mm 10bag experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material no:323000 batch no: 0174596.Pet owner reported needles crooked/bent.Inconsistent needle color, stated that some of the needles appear to have a dull rather than shiny.Some of the syringes have tiny cracks on barrel towards the top.Consumer does not re-use.

• Brand Name: SYRINGE 0.3ML VET U40 29GA 12.7MM 10BAG
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11996411
• Report Number: 1920898-2021-00664
• Device Sequence Number: 805104
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/23/2021

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: Other
• Device Expiration Date: 06/30/2025
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 0174596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1