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

Catalog Number 47513302

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2018

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 syringe was difficult to operate.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Unconfirmed, no sample received.Dhr review of the release paperwork was performed.No issues detected.Batch was released under acceptance criteria.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer but not correlate this symptom with a potential cause linked to bd process.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.

Event Description

It was reported that the bd ultrasafe plus x100l syringe was difficult to operate.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Unconfirmed, no sample received.Dhr review of the release paperwork was performed.No issues detected.Batch was released under acceptance criteria.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer but not correlate this symptom with a potential cause linked to bd process.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.

Event Description

It was reported that the bd ultrasafe plus x100l syringe was difficult to operate.There was no report of exposure, injury, or medical intervention.

• 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: 8051738
• MDR Text Key: 126656003
• Report Number: 3001741852-2018-00026
• Device Sequence Number: 1
• Product Code: FMF
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2020
• Device Catalogue Number: 47513302
• Device Lot Number: 9233075
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other