MAUDE Adverse Event Report: BECTON DICKINSON ULTRASAFE PLUS X100L PR GREEN CCL AMG; NEEDLE GUARD

Catalog Number 47474302

Device Problem Failure to Deliver (2338)

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

Event Date 11/16/2019

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 the ultrasafe plus x100l pr green ccl amg was unable to deliver insulin/medication during use.The following information was provided by the initial reporter: report states that one (1) product syringe did not work properly.No other information is available.

Manufacturer Narrative

Investigation summary: a sample was not returned for evaluation.Batch record review did not indicate any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.Based on the investigation, bdm-ps was not able to confirm the symptom perceived by the customer and not correlate this symptom with a potential cause linked to bd process.

Event Description

It was reported that the ultrasafe plus x100l pr green ccl amg was unable to deliver insulin/medication during use.The following information was provided by the initial reporter: report states that one (1) product syringe did not work properly.No other information is available.

• Brand Name: ULTRASAFE PLUS X100L PR GREEN CCL AMG
• Type of Device: NEEDLE GUARD
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• MDR Report Key: 9456083
• MDR Text Key: 191320742
• Report Number: 3001741852-2019-00078
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

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: 03/16/2023
• Device Catalogue Number: 47474302
• Device Lot Number: 9195729
• Initial Date Manufacturer Received: 11/16/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 11/16/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other