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

Catalog Number 515302

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 03/18/2019

Event Type  Injury  

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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1011101; medical device expiration date: 2022-04-30; device manufacture date: 2019-01-10; medical device lot #: 1011464; medical device expiration date: 2022-08-31; device manufacture date: 2019-02-28; medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.(b)(6).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 is allowing air bubbles to form in the tube.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?).Problem occured 15 times.

Manufacturer Narrative

Investigation: dhr review was done and no issues were reported during production of this lots.No sample received for this complaint, picture was 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 caused molding deficit on one side of component.Capa#891423 was initiated.

Event Description

It was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.

Manufacturer Narrative

The following fields have been updated with corrections: short description: pr# 856106, leakage and chemotherapeutic medication exposure (04/11).Describe event or problem: it was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.Type of reportable events: serious injury.

Event Description

It was reported that bd phaseal¿ secondary set c61 has leakage and caused chemotherapeutic medication exposure.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: phaseal c-61 is leaking (drops are coming from the plastic part above the tubing, and nurses have had drops on them).Even if there are no drops, the hoses are getting air from somewhere and the air bubbles make it impossible to administer the infusion via pumps.So this is a complaint on two problems wit c61: 1.Leakage 2.Air bubbles in the tubing.Customer will not use c61 until we have an explanation and solution (replacement product?) problem occured 15 times.

• 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: 8474960
• MDR Text Key: 145092604
• Report Number: 2243072-2019-00632
• Device Sequence Number: 0
• Product Code: LHI
• 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,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515302
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other