MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

Catalog Number 324916

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 0.3ml 31ga 6mm halfunit 10bagsla hub separated.The following information was provided by the initial reporter: when inserting the syringe in the ampoule bottle and aspirating the insulin, the needle detached itself from the body of the syringe (together with the plastic part) and got stuck in the rubber of the bottle.Customer mentioned that she had difficulty removing the protective cap from the syringe.

Event Description

It was reported that syringe 0.3ml 31ga 6mm half unit 10bagsla hub separated.The following information was provided by the initial reporter: when inserting the syringe in the ampoule bottle and aspirating the insulin, the needle detached itself from the body of the syringe (together with the plastic part) and got stuck in the rubber of the bottle.Customer mentioned that she had difficulty removing the protective cap from the syringe.

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# 0020542.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.

• Brand Name: SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11362104
• MDR Text Key: 233053530
• Report Number: 1920898-2021-00199
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

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: Lay User/Patient
• Device Catalogue Number: 324916
• Device Lot Number: 0020542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 03/25/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1