MAUDE Adverse Event Report: BECTON DICKINSON ULTRASAFE PLUS X100L PNG CLEAR AMG; NEEDLE GUARD

Catalog Number 47452101

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.Investigation summary: unconfirmed, no sample received.Investigation conclusion: 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.Root cause description: 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.Batch record review did not indicate of any incident in relation to the problem statement.Batch was released in accordance to the acceptable criteria.

Event Description

It was reported that the ultrasafe plus x100l png clear 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 PNG CLEAR AMG
• Type of Device: NEEDLE GUARD
• Manufacturer (Section D): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• Manufacturer (Section G): BECTON DICKINSON; faraday road; dorcan; swindon wiltshire SN3 5 JH; UK SN3 5JH
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9447050
• MDR Text Key: 191320611
• Report Number: 3001741852-2019-00077
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 47452101
• Device Lot Number: 8075654
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other