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

Model Number	323000
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2332719.Medical device expiration date: 31-dec-2027.Device manufacture date: 28-nov-2022.Medical device lot #: 2003427.Medical device expiration date: 31-jan-2027.Device manufacture date: 03-jan-2022.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 an unspecified number of bd¿ pet syringes veterinary insulin syringes from lots 2332719 and 2003427 had slanted scale markings.The following information was provided by the initial reporter: "pet owner reported "scale markings" on some of the barrels are not straight.Stated, the markings are "slanted"? stated, two boxes affected".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: h6: investigation summary: the customer returned (9) 0.3ml 29ga syringes, reporting scale markings as defective.The syringes were visually examined and observed scale markings defective on the barrel.Upon visual examination, embecta was able to confirm the customer-indicated failure.A review of the device history record was completed for batch #2003427 all inspections were performed per the applicable operations qc specifications.No root cause can be determined.
Event or Problem Description
It was reported that an unspecified number of bd¿ pet syringes veterinary insulin syringes from lots 2332719 and 2003427 had slanted scale markings.The following information was provided by the initial reporter: "pet owner reported "scale markings" on some of the barrels are not straight.Stated, the markings are "slanted"? stated, two boxes affected".
Event or Problem Description
It was reported that an unspecified number of bd¿ pet syringes veterinary insulin syringes from lots 2332719 and 2003427 had slanted scale markings.The following information was provided by the initial reporter: "pet owner reported "scale markings" on some of the barrels are not straight.Stated, the markings are "slanted"? stated, two boxes affected".
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.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• 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: 16640347
• Report Number: 1920898-2023-00171
• Device Sequence Number: 6048793
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 07/20/2023

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: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 07/20/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 04/30/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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