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

Model Number	323000
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd pet syringes veterinary insulin syringes the plunger was loose.There was no report of patient impact.The following information was provided by the initial reporter: pet owner stated, two syringes are used per day.Stated, the plunger rod is really loose stated, scale marking fonts are larger at top of barrel and much smaller at the bottom of barrel stated, sometimes font is so small that he cannot see the numbers.Lot: 2206995 catalog: date of event: unknown samples: yes cl u40 syringe complaint received voicemail from pet owner stating he's finding "bent needles" prior to injection stated, barrel sizes seem different, "some are large and same are small".
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-aug-2023 h6: investigation summary customer returned (6) 0.3ml 12.7mm syringes in an open polybag from the lot# 2206995.It was reported by the consumer that the plunger rod is really loose.All the syringes outer diameter was measured within the specified limits.Functionality test was performed and no issues were observed with the movement of plunger rod.No evidence of loose plunger rod was observed on the returned samples.A review of the device history record was completed for batch # 2206995 all inspections were performed per the applicable operations qc specifications.Embecta was not able to confirm the customer indicated issue.Root cause cannot be determined as the issue is unconfirmed.See h10.
Event or Problem Description
It was reported while using bd pet syringes veterinary insulin syringes the plunger was loose.There was no report of patient impact.The following information was provided by the initial reporter: pet owner stated, two syringes are used per day.Stated, the plunger rod is really loose stated, scale marking fonts are larger at top of barrel and much smaller at the bottom of barrel stated, sometimes font is so small that he cannot see the numbers.Lot: 2206995 catalog: date of event: unknown samples: yes cl u40 syringe complaint received voicemail from pet owner stating he's finding "bent needles" prior to injection stated, barrel sizes seem different, "some are large and same are small.".

• Brand Name: BD PET SYRINGES VETERINARY INSULIN SYRINGES
• 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: 17220252
• Report Number: 1920898-2023-00402
• Device Sequence Number: 3022333
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: (01)00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: Other
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 2206995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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