MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 1/2ML INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326666

Device Problem Separation Problem (4043)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

It was reported that the bd ultra-fine¿ 1/2ml insulin syringe experienced hub separation from the device.The following information was provided by the initial reporter: this is a report about needle/shied separation.According to the customer's report, the needle with the shied was separated from the barrel when the shield was removed.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 23-mar-2023.H6: investigation summary: customer returned one 0.3 ml syringe inside a small zipper bag.It was reported from the customer that the needle with the shied was separated from the barrel when the shield was removed.The returned syringe was visually inspected, and no issues were found.The hub and the shield were attached properly.The shieled then was removed and attached more than 10 times and did not cause any hub separation.Due to the batch being unknown, no dhr review can be completed.Based on the samples received, embecta was not able to confirm the customer¿s indicated failure.Since the issue is not confirmed, the root cause can not be determined.H3 other text : see h10.

Event Description

It was reported that the bd ultra-fine¿ 1/2ml insulin syringe experienced hub separation from the device.The following information was provided by the initial reporter: this is a report about needle/shied separation.According to the customer's report, the needle with the shied was separated from the barrel when the shield was removed.

• Brand Name: BD ULTRA-FINE¿ 1/2ML 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16524789
• MDR Text Key: 311253123
• Report Number: 1920898-2023-00110
• 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: 06/02/2023

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: 326666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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