MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	328466
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the cannula length was insufficient.There was no report of patient impact.The following information was provided by the initial reporter: pharmacy reported found the needles to be of different lengths within this box.Their patient returned to the store.They did not provide replacement box to the patient.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-feb-2023.H6: investigation summary: customer returned a total of (19) 0.5ml 30ga 1/2in syringes, 9 in an open sealed and 10 in a sealed bag.Customer reported needles to be of different lengths.The returned samples(19) were measured for cannula length using comparator and all the needles cannula length was measured within the specified acceptance limits (+/- 0.047).Hence, the alleged issue could not be confirmed based on the samples return.A review of the device history record was completed for batch# 1207789.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 failure.Root cause cannot be determined at this time as the issue is unconfirmed.
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the cannula length was insufficient.There was no report of patient impact.The following information was provided by the initial reporter: pharmacy reported found the needles to be of different lengths within this box.Their patient returned to the store.They did not provide replacement box to the patient.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• 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: 16251471
• Report Number: 1920898-2023-00029
• Device Sequence Number: 5472969
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: (01)00382908466035
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 04/20/2023

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 Expiration Date: 08/31/2026
• Device Model Number: 328466
• Device Catalogue Number: 328466
• Device Lot Number: 1207789
• 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: 01/09/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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