MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ SECONDARY SET C61; ADMINISTRATION SET

Catalog Number 515302

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd phaseal¿ secondary set c61 leaked.The following information was provided by the initial reporter: in ward, where they are giving cytostatics to patient, they found out a leakage from c61.Leakage came from tube, where it connects to spike.Two patients and a nurse exposed to cytotoxic steam.

Manufacturer Narrative

Investigation: dhr review was done and no issues were reported during production of this lot.No sample received for this complaint, picture was not provided.Ct scan was done on leaking sample which was segregated during production.After this scan additional tests were done on spike component and concentricity of lower part of spike component which caused molding deficit on one side of component.Capa#891423 was initiated.

Event Description

It was reported that bd phaseal¿ secondary set c61 leaked.The following information was provided by the initial reporter: in ward, where they are giving cytostatics to patient, they found out a leakage from c61.Leakage came from tube, where it connects to spike.Two patients and a nurse exposed to cytotocsic steam.

• Brand Name: BD PHASEAL¿ SECONDARY SET C61
• Type of Device: ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8597196
• MDR Text Key: 148430069
• Report Number: 2243072-2019-00895
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00382905153020
• UDI-Public: 382905153020
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515302
• Device Lot Number: 1011787
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other