MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PLUS X100L PNG CLEAR; SYRINGE, ANTISTICK

Catalog Number 47451130

Device Problem Failure to Deliver (2338)

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

Event Date 10/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Initial reporter phone #: 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 the pen did not click into place and the needle did not come out with a bd ultrasafe¿ plus x100l png clear.The following information was provided by the initial reporter: the general practitioner could not push the button down and the pen did not click, no needle came out and no fluid came out.The needle did not penetrate the skin of the patient.While looking through the inspection window, the fluid is still visible.

Event Description

It was reported that the pen did not click into place and the needle did not come out with a bd ultrasafe¿ plus x100l png clear.The following information was provided by the initial reporter: the general practitioner could not push the button down and the pen did not click, no needle came out and no fluid came out.The needle did not penetrate the skin of the patient.While looking through the inspection window, the fluid is still visible.

Manufacturer Narrative

H.6.Investigation summary: despite several requests to customer, bd cannot get clarification on the product involved in the complaint.The customer gives an ultrasafe batch in his complaint, but explains an issue with a pen.Bd does not sell any pen to this customer, and ultrasafe cannot be used with a pen.The only product could be the barrel, but as the customer does not give bd any cat number or batch number, the investigation cannot be conducted.¿ bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process h3 other text : see section h.10.

• Brand Name: BD ULTRASAFE PLUS X100L PNG CLEAR
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• MDR Report Key: 9285468
• MDR Text Key: 216634660
• Report Number: 3009081593-2019-00244
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K123743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 47451130
• Device Lot Number: 9050671
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other