MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	328411
Medical Device Problem Code	Leak/Splash (1354)
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
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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 ultra-fine¿ insulin syringe was leaking.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.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.H3 other text : see h10.
Event or Problem Description
It was reported that the bd ultra-fine¿ insulin syringe was leaking.Verbatim: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 23-jan-2024.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.
Event or Problem Description
It was reported that the bd ultra-fine¿ insulin syringe was leaking.The following information was provided by the initial reporter: daughter of consumer reported when injecting.Insulin leaks out of the hub, where meeting the barrel of syringe.Resulting of wasting of insulin.It runs down.Stomach/site daughter of consumer reported needle hub separates at times from syringe too.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17936490
• Report Number: 1920898-2023-00712
• Device Sequence Number: 20421074
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: (01)00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/25/2024

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: 02/28/2026
• Device Catalogue Number: 328411
• Device Lot Number: 1026137
• 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: 10/02/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 01/25/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 11/06/2023; 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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