MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ INFUSION SET (C61)

Catalog Number 515302

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 a bd phaseal¿ infusion set (c61) had.The following was reported, "leakage from c61.They have noticed the leakage at department when starting infusion to patient.This same have occurred 3 times during this month.".

Event Description

It was reported that a bd phaseal¿ infusion set (c61) had.The following was reported, " leakage from c61.They have noticed the leakage at department when starting infusion to patient.This same have occurred 3 times during this month.".

Manufacturer Narrative

H.6.Investigation: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint.A ct scan was done on a leaking sample which was segregated during production.After this scan additional tests were done on spike component.The probably root cause was found to be the lower part of the spike component which caused molding deficit on one side of the component.Capa#891423 was initiated.

• Brand Name: BD PHASEAL¿ INFUSION SET (C61)
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8448281
• MDR Text Key: 139883397
• Report Number: 2243072-2019-00562
• Device Sequence Number: 1
• Product Code: LHI
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

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: 08/31/2022
• Device Catalogue Number: 515302
• Device Lot Number: 1011464
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/25/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other