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

Catalog Number	328438
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle was clogged during the insulin injection.This complaint was created to capture the 5th of 5 related incidents.The following information was provided by the initial reporter: "reported issue: needle bends easily, syringe plug gets stuck.Have to poke several times to get thru skin.Add info received on 17-oct-2023.1st customer response ¿ are you able to provide the incident date?: there was more than one date that the incident occurred.The incident occurred multiple times during the month of (b)(6).¿ was there a delay of, or change in, the course of treatment due to the event?: yes, provider would have to switch syringes due to needle bending and not penetrating the skin and provider/patient would need to make multiple attempts of injecting at the injection site.¿ what type of procedure is being performed?: injection.¿ what was the medication/fluid in use at the time of the event?: semaglutide".
Event or Problem Description
It was reported that the bd insulin syringe with the bd ultra-fine¿ needle was clogged during the insulin injection.This complaint was created to capture the 5th of 5 related incidents.The following information was provided by the initial reporter: "reported issue: needle bends easily, syringe plug gets stuck.Have to poke several times to get thru skin.Add info received on 17-oct-2023 1st customer response are you able to provide the incident date? there was more than one date that the incident occurred.The incident occurred multiple times during the month of september.9/18, 9/22, 9/27, 9/29, 10/2 was there a delay of, or change in, the course of treatment due to the event? yes, provider would have to switch syringes due to needle bending and not penetrating the skin and provider/patient would need to make multiple attempts of injecting at the injection site.What type of procedure is being performed? injection.What was the medication/fluid in use at the time of the event? semaglutide".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 06-nov-2023.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: BD INSULIN SYRINGE WITH THE 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17966972
• Report Number: 1920898-2023-00731
• Device Sequence Number: 7669963
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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 Catalogue Number: 328438
• Device Lot Number: 3107190
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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