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

Catalog Number 47513302

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

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 a bd ultrasafe¿ plus x100l had leakage.The following was reported, "complainant i (pharmacy) reported, that a patient reported, that one out of two cosentyx psfs leaked.The patient is very experienced with cosentyx and realized that something is wrong with the product.When inspecting the syringe, the patient saw, that the plunger is loose and that liquid leaking out between the syringe and the plunger.

Manufacturer Narrative

Investigation: batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.A sample was not returned so the complaint could not be confirmed and a root cause could not be determined.

Event Description

It was reported that a bd ultrasafe¿ plus x100l had leakage.The following was reported, "complainant i (pharmacy) reported, that a patient reported, that one out of two cosentyx psfs leaked.The patient is very experienced with cosentyx and realized that something is wrong with the product.When inspecting the syringe, the patient saw, that the plunger is loose and that liquid leaking out between the syringe and the plunger.

• Brand Name: BD ULTRASAFE PLUS X100L
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 8457923
• MDR Text Key: 140161011
• Report Number: 3001741852-2019-00005
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382904751333
• UDI-Public: 382904751333
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/10/2022
• Device Catalogue Number: 47513302
• Device Lot Number: 1712674
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other