MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 0.5ML SYRINGE; PISTON SYRINGE

Model Number 328279

Device Problem Material Separation (1562)

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

Event Date 10/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.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 bd 0.5ml syringe experienced hub separation from the device.The following information was provided by the initial reporter: i use the bd insulin syringes every day.I am seeing a problem with the1/2 ml ultra fine needle syringe.I find it hard to remove the protective caps, both orange and white.Twice now, in removing the orange cap, the needle has been broken off, and sits in the cap.Then, because the cap is s tight on the syringes, the little plastic cap that surrounds the needle is loose, and i have to tighten it.I can see where this would be an issue.I not only want comfort, but ease, and want to feel confident that the syringe will work properly, my getting an accurate dose, and it won't leak.

Event Description

It was reported that the bd 0.5ml syringe experienced hub separation from the device.The following information was provided by the initial reporter: i use the bd insulin syringes every day.I am seeing a problem with the1/2 ml ultra fine needle syringe.I find it hard to remove the protective caps, both orange and white.Twice now, in removing the orange cap, the needle has been broken off, and sits in the cap.Then, because the cap is s tight on the syringes, the little plastic cap that surrounds the needle is loose, and i have to tighten it.I can see where this would be an issue.I not only want comfort, but ease, and want to feel confident that the syringe will work properly, my getting an accurate dose, and it won't leak.

Manufacturer Narrative

H.6.Investigation: 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# 0349289.All inspections and challenges were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h.10.

• Brand Name: BD 0.5ML 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12756945
• MDR Text Key: 280589157
• Report Number: 1920898-2021-01158
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282791
• UDI-Public: 00382903282791
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328279
• Device Catalogue Number: 328279
• Device Lot Number: 0349289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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