MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES VETERINARY INSULIN SYRINGE; PISTON SYRINGE

Model Number	323000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd pet syringes veterinary insulin syringe broke.The following information was provided by the initial reporter: when he tried to remove the syringe, the vial fell on the floor and broke with the needle/syringe in it.
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 bd pet syringes veterinary insulin syringe broke.The following information was provided by the initial reporter: when he tried to remove the syringe, the vial fell on the floor and broke with the needle/syringe in it.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 22-mar-2023.H6: investigation summary customer returned 3 vet syringe 0.3ml x 29g x 12.7mm loose.It was reported by the consumer that 1 needle broke during use, 1 needle clogged during injection and was difficult to operate / unable to move plunger.1 needle had burred needle.All the returned samples were visually examined.Observed one syringe with broken plunger cap, damaged cap and deformed barrel at plunger cap insert.Other syringe with plunger cap broken.All the return samples were tested for npi using microscope and found no issues that could lead to needle separates from the vail.Functionality test was performed and no issues were observed with syringe difficult to operate, plunger movement and clog.No issues were observed with needle hub separated on the return samples.A review of the device history record was completed for batch# 2136583.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, embecta was not able to confirm the customer indicated issue hub separated.Root cause cannot be determined as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: BD PET SYRINGES VETERINARY INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16534889
• Report Number: 1920898-2023-00124
• Device Sequence Number: 17739563
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: (01)00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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 Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 06/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown