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

Catalog Number 328438

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

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 plunger on the bd insulin syringe with the bd ultra-fine¿ needle was difficult to move, and applying more pressure to it during use caused the injection site to bleed.The consumer reported 2 occurrences of this event.The following information was provided by the initial reporter: "item 328438 lot # 8169629 exp 2023-7-31 finding plunger hard to move up and down.Applies more pressure and site bleeds.Using lantus does not reuse.".

Manufacturer Narrative

Investigation summary: customer returned (3) loose 0.3ml 31g 8mm bd insulin syringes (used), and (10) sealed 0.3ml 31g 8mm bd insulin syringes (unused).Consumer stated finding plunger hard to move up and down, applies more pressure and site bleeds.All (13) returned syringes were examined and exercised, and none exhibited plunger rods that were difficult to move, therefore the alleged defects could not be confirmed.A review of the device history record was completed for batch# (b)(4).All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failures.Root cause cannot be determined at this time as the issue is unconfirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.

Event Description

It was reported that the plunger on the bd insulin syringe with the bd ultra-fine¿ needle was difficult to move, and applying more pressure to it during use caused the injection site to bleed.The consumer reported 2 occurrences of this event.The following information was provided by the initial reporter: "item 328438 lot # 8169629 exp 2023-07-31 finding plunger hard to move up and down.Applies more pressure and site bleeds.Using lantus does not reuse.".

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8433545
• MDR Text Key: 139320059
• Report Number: 1920898-2019-00269
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908438032
• UDI-Public: 00382908438032
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 328438
• Device Lot Number: 8169629
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other