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

Model Number	328519
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd insulin syringes with bd ultra-fine¿ needle the cannula broke.There was no report of patient impact.The following information was provided by the initial reporter: customer stated : she emailed about relion needles & syringes 6mmx31g.When she uses these they get stuck in her arm.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: unable to perform complaint lot history check for breaks off during use due to unknown lot number.The occurrence is unknown since the lot number is unknown.This will be considered the 1st related complaint for guidance on the investigation.Investigation summary: no samples including photos were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Due to the batch being unknown, no dhr review can be completed.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

• 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: 16318501
• Report Number: 1920898-2023-00043
• Device Sequence Number: 18167434
• Product Code: FMI
• UDI-Device Identifier: 00681131138345
• UDI-Public: (01)00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2023

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: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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