MAUDE Adverse Event Report: BECTON DICKINSON BD¿ DEHP FREE INFUSION SET; IV TUBING

Catalog Number 590502

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Results: a sample was returned for evaluation.A hair was found inside the iv tube.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: based on the investigation result of the complaint case the hair inside the iv set tube was a human hair.We suppose that when the two parts(sleeve stopper and y-connector) were assembled together, a hair may have stuck onto one of them and flowed inside the y-connector due to static electricity.Defect due to insufficient cleanness of work stand or work floor or smock.Capa (b)(4) has been opened.(b)(4).

Event Description

It was reported that a hair was found in the tubing of a bd¿ dehp free infusion set during use.No injury or medical intervention.

• Brand Name: BD¿ DEHP FREE INFUSION SET
• Type of Device: IV TUBING
• 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: 6810329
• MDR Text Key: 83312041
• Report Number: 2243072-2017-00090
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K150059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/09/2020
• Device Catalogue Number: 590502
• Device Lot Number: 2704101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2017
• 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