MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PLUS X100L; NEEDLE GUARD

Catalog Number 47513302

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem Underdose (2542)

Event Date 07/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 ultrasafe¿ plus x100l was used with the needle to help inject cosentx into the subcutaneous layer during use, but the plunger would not go in further, and upon removing the needle from the patient's leg, a small amount of drug was found not to be injected.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the patient advised that she did her first subcutaneous injection of cosentx and thought the plunger would not go in any more however when she removed the needle from her leg there was a very small amount of drug not injected.".

Manufacturer Narrative

Investigation summary: a full root cause analysis could not be conducted with the available information and is closed without a conclusion.Until samples are available no further investigation will be carried out.Batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.

Event Description

It was reported that the bd ultrasafe¿ plus x100l was used with the needle to help inject cosentx into the subcutaneous layer during use, but the plunger would not go in further, and upon removing the needle from the patient's leg, a small amount of drug was found not to be injected.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the patient advised that she did her first subcutaneous injection of cosentx and thought the plunger would not go in any more however when she removed the needle from her leg there was a very small amount of drug not injected.".

• Brand Name: BD ULTRASAFE PLUS X100L
• Type of Device: NEEDLE GUARD
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 8870654
• MDR Text Key: 155699091
• Report Number: 3001741852-2019-00024
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: 47513302
• Device Lot Number: 1712674
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other