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

Catalog Number 326631

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2023

Event Type  malfunction  

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 Description

It was reported that the hub separated from the bd ultra-fine¿ insulin syringe when the cap was removed.The following information was provided by the initial reporter, translated from japanese: "this report is about hub separation.When the cap was removed, the needle hub was taken off.".

Event Description

It was reported that the hub separated from the bd ultra-fine¿ insulin syringe when the cap was removed.The following information was provided by the initial reporter, translated from japanese: "this report is about hub separation.When the cap was removed, the needle hub was taken off.".

Manufacturer Narrative

H6: investigation summary customer returned a total of (19) 0.3ml 29ga 12.7mm syringes from the lot# 2234021, 14 in a sealed polybag, 5 in an open polybag.This report is about hub separation.When the cap was removed, the needle hub was taken off.The returned samples were visually examined and observed no issues, no issues were observed with needle hub separates.No issues of any kind was observed on the returned samples.A review of the device history record was completed for batch# 2234021.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Embecta was not able to confirm the customer indicated issue.Root cause cannot be determined as the issue is unconfirmed.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: 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: 17546613
• MDR Text Key: 321735596
• Report Number: 1920898-2023-00556
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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
• Device Operator: Other
• Device Catalogue Number: 326631
• Device Lot Number: 2234021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2022
• 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
• Treatment: SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP.