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

Catalog Number 928856

Device Problems Failure to Deliver (2338); Difficult to Advance (2920)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 while using the bd ultra-fine¿ insulin syringe the plunger would not move and unable to deliver medication.The following was received by the initial reporter: this 1 syringe was filled about 30mts before he attempted to use and found the plunger would not move.Infomed caller not to prefill and complete injections right after filling.I had a catstophe happen with a syringe purchased at your xxx.I was going out to eat and loaded syringes to take with me.During breakfast one syringe refused to inject, the pump refused to inject no matter how hard i pushed.

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1242591.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.

Event Description

It was reported while using the bd ultra-fine¿ insulin syringe the plunger would not move and unable to deliver medication.The following was received by the initial reporter: this 1 syringe was filled about 30mts before he attempted to use and found the plunger would not move.Infomed caller not to prefill and complete injections right after filling.I had a catstophe happen with a syringe purchased at your xxx.I was going out to eat and loaded syringes to take with me.During breakfast one syringe refused to inject, the pump refused to inject no matter how hard i pushed.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17547262
• MDR Text Key: 321775101
• Report Number: 1920898-2023-00558
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: (01)00311917048130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 928856
• Device Lot Number: 1242591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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