MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

Model Number	328466
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 1039673, medical device expiration date: 2026-02-28, device manufacture date: 2021-02-08.
Event or Problem Description
It was reported that 2 bd insulin syringes with the bd ultra-fine¿ needles experienced scale marking issues.The following information was provided by the initial reporter: this is now the second box of syringes i have purchased that contains syringes with inconsistent markings.We cannot inject a consistent insulin dose because the markings are not same on all the syringes.
Event or Problem Description
It was reported that 2 bd insulin syringes with the bd ultra-fine¿ needles experienced scale marking issues.The following information was provided by the initial reporter: this is now the second box of syringes i have purchased that contains syringes with inconsistent markings.We cannot inject a consistent insulin dose because the markings are not same on all the syringes.
Additional Manufacturer Narrative
D10: device available for eval yes, d10: returned to manufacturer on: 2021-09-13.Investigation summary: customer returned a total of 17 syringes with 0.5ml graduation marks.Each syringe was checked with gauge bddc-fl-00172 to ensure that the graduation markings were properly aligned.5 of the 17 returned samples featured a misaligned 5 unit mark.All syringes were within specifications at the 50 unit mark.A review of the device history record was completed for batch# 1039673.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause for this defect cannot be determined.H3 other text : see h10.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12367079
• Report Number: 1920898-2021-00927
• Device Sequence Number: 3974182
• Product Code: FMF
• UDI-Device Identifier: 00382908466035
• UDI-Public: 00382908466035
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: 328466
• Device Catalogue Number: 328466
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1