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	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/25/2020
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 a vet syringe 0.3ml x 29g x 12.7mm 10 bag had scale marking issues during use.The following was reported by the initial reporter: "it was reported that the u-40 syringes are causing the pet owner to use the insulin quicker and she believes she is measuring the dose incorrectly.Also, the pet's numbers have fluctuated and the pet is more tired lately.Verbatim: pet owner stated she has u-100 insulin and was prescribed the u-100 syringes.Stated the pharmacy informed her of the u-40 syringes and advised she should try them.Pet owner stated she is using the insulin quicker then what she should be.Stated she gives 4 units a day and believes she is measuring the doses incorrectly resulting in using the insulin faster.Stated her pet's numbers have been fluctuating and her pet is more tired lately.It was recommended that pet owner consult with her vet.".
Event or Problem Description
It was reported that a vet syringe 0.3ml x 29g x 12.7mm 10 bag had scale marking issues during use.The following was reported by the initial reporter: "it was reported that the u-40 syringes are causing the pet owner to use the insulin quicker and she believes she is measuring the dose incorrectly.Also, the pet's numbers have fluctuated and the pet is more tired lately.Verbatim: pet owner stated she has u-100 insulin and was prescribed the u-100 syringes.Stated the pharmacy informed her of the u-40 syringes and advised she should try them.Pet owner stated she is using the insulin quicker then what she should be.Stated she gives 4 units a day and believes she is measuring the doses incorrectly resulting in using the insulin faster.Stated her pet's numbers have been fluctuating and her pet is more tired lately.It was recommended that pet owner consult with her vet.".
Additional Manufacturer Narrative
H.6.Investigation: 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.

• 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: 11060876
• Report Number: 1920898-2020-01748
• Device Sequence Number: 11413596
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 11/25/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 12/22/2020
• 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