MAUDE Adverse Event Report: BECTON DICKINSON BD MICROCLAVE® STABILIZED EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 201-0016

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is building 8195 and madison.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H.3.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 microclave® stabilized extension set was blocked and wouldn't flush the tubing.The following information was provided by the initial reporter: "we had a pivo compatible extension set.Fail on (b)(6) 2023.The extension set would not flush, draw backing back blood but not flushing any fluid through the tubing.No, we did not experience any adverse events as a result of the reported failure, no medications were being used with the product, there were no indicators that the product would not work prior to failure, and the product was switched out with a different lot and the procedure was successfully completed.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 16-may-2023.H6: investigation summary : our quality engineer inspected the sample submitted for evaluation.Bd received one device from reference number (b)(4), lot number 9452920.The sample was examined for any visual indications of occlusion in the tubing and the t-port.There were no visual indications of occlusion observed, aside from some remnants of dried blood within the tubing.Water was then flushed and aspirated through both the t-port and the extension tubing.No difficulty was found when aspirating or flushing water through either port.We were unable to confirm the reported issue.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that the bd microclave® stabilized extension set was blocked and wouldn't flush the tubing.The following information was provided by the initial reporter: "we had a pivo compatible extension set.Fail on (b)(6) 2023.The extension set would not flush, draw backing back blood but not flushing any fluid through the tubing.No, we did not experience any adverse events as a result of the reported failure, no medications were being used with the product, there were no indicators that the product would not work prior to failure, and the product was switched out with a different lot and the procedure was successfully completed.".

• Brand Name: BD MICROCLAVE® STABILIZED EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17007753
• MDR Text Key: 315998864
• Report Number: 2243072-2023-00890
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 201-0016
• Device Lot Number: 9452920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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