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

Model Number	323000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6), usa has been used as a default.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 an unspecified number of vet syringe 0.3ml x 29g x 12.7mm 10 bag broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle head comes off when the cap is removed.Verbatim: email received¿2020-11-17 14:30:21.I purchase a box of 100 pet syringes and several have been defective.Needle head comes off when cap is removed.Lot # 9266921.
Event or Problem Description
It was reported that an unspecified number of vet syringe 0.3ml x 29g x 12.7mm 10 bag broke at the cannula during use.The following was reported by the initial reporter: "it was reported that the needle head comes off when the cap is removed.Verbatim: email received: (b)(6) 2020, 14:30:21.I purchase a box of 100 pet syringes and several have been defective.Needle head comes off when cap is removed.Lot # 9266921.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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 as no samples or photos were returned.H3 other text : see h10.

• Brand Name: VET SYRINGE 0.3ML X 29G X 12.7MM 10 BAG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10988600
• Report Number: 1920898-2020-01701
• Device Sequence Number: 14322219
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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 Expiration Date: 10/31/2024
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 9266921
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1