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

Catalog Number 320468

Device Problem Defective Device (2588)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint lot history check was performed on lot # 0041226 for needle hub separates.This is the 1st related complaint for needle hub separates on lot # 0041226.A review of risk management 150rmn-0001-16 revision 14 indicates that the potential risk of this specific reported incident (syringe, unable to perform function) was captured and addressed.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 0041226.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200878340] noted that did not pertain to the complaint.There was one (1) notification [200878718] noted for out of spec shield pull as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that the bd ultra-fine ii¿ insulin syringe was damaged and didn't have the cap attached.The following information was provided by the initial reporter: "i'm just writing about a syringe i had in a box the cap wasn't attached or usable.The lot number on the bag is 0041226 y.".

• Brand Name: BD ULTRA-FINE II 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11418363
• MDR Text Key: 251446050
• Report Number: 1920898-2021-00267
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/11/2021

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: 320468
• Device Lot Number: 0041226
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2020
• 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