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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD PHASEAL¿ INFUSION SET (C61); ADMINISTRATION SET
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BECTON DICKINSON BD PHASEAL¿ INFUSION SET (C61); ADMINISTRATION SET Back to Search Results
Catalog Number 515302
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 02/26/2019
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.(b)(6).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 leakage.The report is as follows, "prepared the chemotherapy drug at the pharmacy and in the beginning it was not wet, just normal.The bag with the drug was sent to the ward and they observed that it was wet and leaking from the c61 connection.It was before it was attached it to the patient.The bag with the drug was then sent back to the to the pharmacy where it was destroyed and a new bag was prepared.No leakage here.We will receive another c61 from the same batch and will also send pictures.It was loose (rotated in place) and when our pharmacist pulled it gently, it just came off.".
 
Manufacturer Narrative
The correction is as follows: device manufacture date: 2018-09-01.
 
Event Description
It was reported that a bd phaseal¿ infusion set (c61) had leakage.The report is as follows, "prepared the chemotherapy drug at the pharmacy and in the beginning it was not wet, just normal.The bag with the drug was sent to the ward and they observed that it was wet and leaking from the c61 connection.It was before it was attached it to the patient.The bag with the drug was then sent back to the to the pharmacy where it was destroyed and a new bag was prepared.No leakage here.We will receive another c61 from the same batch and will also send pictures.It was loose (rotated in place) and when our pharmacist pulled it gently, it just came off.".
 
Manufacturer Narrative
H.6.Investigation: dhr review was done and no issues were reported during production of this lot.No sample was 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 the spike component and concentricity of the lower part of the spike component was the cause of the molding deficit on one side of the component.Capa#891423 has been initiated.
 
Event Description
It was reported that a bd phaseal¿ infusion set (c61) had leakage.The report is as follows, "prepared the chemotherapy drug at the pharmacy and in the beginning it was not wet, just normal.The bag with the drug was sent to the ward and they observed that it was wet and leaking from the c61 connection.It was before it was attached it to the patient.The bag with the drug was then sent back to the to the pharmacy where it was destroyed and a new bag was prepared.No leakage here.We will receive another c61 from the same batch and will also send pictures.It was loose (rotated in place) and when our pharmacist pulled it gently, it just came off.".
 
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Brand Name
BD PHASEAL¿ INFUSION SET (C61)
Type of Device
ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8430080
MDR Text Key142664943
Report Number2243072-2019-00509
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00382905153020
UDI-Public382905153020
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2022
Device Catalogue Number515302
Device Lot Number1011464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2019
Date Manufacturer Received02/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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