MAUDE Adverse Event Report: BECTON DICKINSON BD¿ DOSI-FLOW 10; IV SET CONNECTOR

Catalog Number REF259-0260-ZLE

Device Problem Material Discolored (1170)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

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 junction between the regulator and the extension line of a bd¿ dosi-flow 10 was found to be brown prior to use.There was no report of injury or medical intervention.

Manufacturer Narrative

Results: four returned complaint samples were visually inspected.The presence of a brown substance in the tubing and in the body was confirmed.Twenty five retained units of the same lot number were visually inspected.No brown substance or any other kind of foreign matter was found in any of the samples.The dhr of the affected lot number has been reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the control done before the release of this product.Conclusion: according to the results obtained, it seems that the brown substance comes from the assembling machine.This is a random error during the manufacturing process that was not detected during the controls done to the units during manufacturing and before its release.No capa is required.

• Brand Name: BD¿ DOSI-FLOW 10
• Type of Device: IV SET CONNECTOR
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7059733
• MDR Text Key: 93450473
• Report Number: 2243072-2017-00267
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/02/2020
• Device Catalogue Number: REF259-0260-ZLE
• Device Lot Number: 170146L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2017
• 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