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

Model Number	328468
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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: consumer reported that that needle separated from the hub from one syringe and an additional syringe was missing the thumb press,unble to read the lot number.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 09jun2023 h6: investigation summary unable to perform complaint lot history check for needle separates from hub due to unknown lot number.The occurrence is unknown since the lot number is unknown.Investigation summary: the customer returned (2) 0.5 ml 31ga 8mm syringes, reporting needle separates from hub.The syringes were visually inspected and observed broken barrel tip on (1) syringe, missing thumb press and damaged plunger cap on the (2) syringe.Based on the samples returned, embecta was able to confirm the customer-indicated failure of needle separates from hub.Manufacturing (holdrege) will be notified of the observed issue.Due to the batch being unknown, no dhr review can be completed.Confirmed: based on the samples received, embecta was able to duplicate or confirm the customer-indicated failure.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 the identification of emerging trends.Issue: needle separates from hub, thumb press missing analysis of sample: a visual inspection of the picture shows a damaged syringe with the needle assembly broken from the barrel of the syringe.H3 other text : see h.10.
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: consumer reported that that needle separated from the hub from one syringe and an additional syringe was missing the thumb press,unble to read the lot number.

• 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 ; 8448235433
• MDR Report Key: 16907093
• Report Number: 1920898-2023-00288
• Device Sequence Number: 5497249
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: (01)00382908468039
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 08/03/2023

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 Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: UNKNOWN
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/16/2023
• 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