MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 328468

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd insulin syringes with bd ultra-fine¿ needle 1/2ml 8mm it was reported by the consumer that needle broke off, caused bleeding, and also 3 needles were missing.The following information was provided by the initial reporter: consumer stated for twenty years on and off, needles have broken off in his skin when taking injection.

Manufacturer Narrative

D4: medical device lot #: 2010796.D4: medical device expiration date: 31-jan-2027.H4: device manufacture date: 10-jan-2022.H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 2010796.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.

Event Description

It was reported that the bd insulin syringes with bd ultra-fine¿ needle 1/2ml 8mm it was reported by the consumer that needle broke off, caused bleeding, and also 3 needles were missing.The following information was provided by the initial reporter: consumer stated for twenty years on and off, needles have broken off in his skin when taking injection.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 8MM
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 15547039
• MDR Text Key: 301730990
• Report Number: 1920898-2022-00688
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: (01)00382908468039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: 2010796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/05/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1