MAUDE Adverse Event Report: BECTON DICKINSON ULTRASAFE X100L PR PLUM SSL NVS STEIN; SYRINGE, ANTISTICK

Catalog Number 47513302

Device Problem Failure to Deliver (2338)

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

Event Date 07/16/2019

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 failure to deliver occurred during use with a ultrasafe x100l pr plum ssl nvs stein.The following information was provided by the initial reporter, "he stated that the patient called and advised the needle never went in his skin and the medication spilled out everywhere.".

Manufacturer Narrative

Investigation summary: no sample received for evaluation.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 full root cause analysis could not be conducted with the available information and is closed without a conclusion.

Event Description

It was reported that failure to deliver occurred during use with a ultrasafe x100l pr plum ssl nvs stein.The following information was provided by the initial reporter, "he stated that the patient called and advised the needle never went in his skin and the medication spilled out everywhere.".

• Brand Name: ULTRASAFE X100L PR PLUM SSL NVS STEIN
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 8871811
• MDR Text Key: 155699047
• Report Number: 3001741852-2019-00026
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382904751333
• UDI-Public: 382904751333
• Combination Product (y/n): N
• PMA/PMN Number: K122558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: Other
• Device Expiration Date: 12/23/2022
• Device Catalogue Number: 47513302
• Device Lot Number: 1735084
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other