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

Model Number	928857
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that the bd insulin syringe - ultra-fine¿ experienced a cannula that broke off.The following information was provided by the initial reporter: consumer reported that the needle broke off in the vial after drawing the insulin.She stated that she was removing the needle from the vial when the needle broke off.
Event or Problem Description
It was reported that the bd insulin syringe - ultra-fine¿ experienced a cannula that broke off.The following information was provided by the initial reporter: consumer reported that the needle broke off in the vial after drawing the insulin.She stated that she was removing the needle from the vial when the needle broke off.
Additional Manufacturer Narrative
The following fields were updated due to additional information: device available for eval: yes returned to manufacturer on: 12-sep-2022.Investigation summary: customer returned (3) loose 0.5ml insulin syringes.The customer reported that the needle broke off in the vial after drawing insulin.The samples were examined, and it was observed that all 3 syringes featured a broken cannula.Microscopic examination of all 3 syringes revealed characteristics such as residual bends on the hub-end of the fractured cannula, and ovality (deformation from the normally circular cross section) ¿ removal of the epoxy made this evident.When viewed together these are all indicators of bending/re-straightening mode of failure.A review of the device history record was completed for batch# 1172392.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 samples and/or photo(s) received the investigation concluded: - confirmed: embecta was able to duplicate or confirm the customer¿s indicated failure (cannula broken) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for this issue is user related.The cannula was broken by the user after handling the syringe.Based on the above, no additional investigation and no capa/sa is required at this time.

• Brand Name: BD INSULIN SYRINGE - ULTRA-FINE¿
• 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: 15272478
• Report Number: 1920898-2022-00577
• Device Sequence Number: 14922736
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• 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): 10/05/2022

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: 07/31/2026
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 1172392
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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