MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES 3/10ML 12.7MM X 29G; 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	01/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date 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 while using bd pet syringes 3/10ml 12.7mm x 29g the scale markings were misaligned.The following information was provided by the initial reporter: material no.323000 batch no.1102439.It was reported that scale markings are crooked.
Additional Manufacturer Narrative
Date of event is unknown; awareness date 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 while using bd pet syringes 3/10ml 12.7mm x 29g the scale markings were misaligned.The following information was provided by the initial reporter: material no.323000 batch no.1102439.It was reported that scale markings are crooked.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-02-07.H6: investigation summary customer returned a total of (12) used 0.3ml, 29 gauge, 12.7mm syringes from lot 1102439.The returned samples were inspected to ensure that using them was as least harmful as intended.When measured, all syringes were found to have graduation marks in their intended locations.While the markings were not perfectly horizontal, the slight angle would not impact usage.The needles were within specifications and did not feature any dullness or burrs that could result in patient harm.A review of the device history record was completed for batch # 1102439 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of the scale being misaligned.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
Event or Problem Description
It was reported while using bd pet syringes 3/10ml 12.7mm x 29g the scale markings were misaligned.The following information was provided by the initial reporter: material no.323000; batch no.1102439.It was reported that scale markings are crooked.

• Brand Name: BD PET SYRINGES 3/10ML 12.7MM X 29G
• 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 ; 8015296192
• MDR Report Key: 13472333
• Report Number: 1920898-2022-00075
• Device Sequence Number: 17451200
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: 00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 02/24/2022

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: 04/30/2026
• Device Model Number: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 1102439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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