Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); STOP COCK
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PHASEAL SECONDARY SET (C62); STOP COCK Back to Search Results
Catalog Number 515312
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2019
Event Type  malfunction  
Manufacturer Narrative
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 the bd phaseal secondary set (c62) experienced a failure to contain blood/medication prior to use.The following information was provided by the initial reporter: c62 secondary set crack.During priming the secondary set c62 with normal saline, leakages occur at the connection part of the connector with the tubing.Small crack shown at the leaking area.Customer has disposed of said tubing.
 
Manufacturer Narrative
H.6.Investigation: one video was provided to our quality team for investigation.The final product for lot ta11681is assembled and packaged at a supplier site.We notified the supplier of the reported issue and provided the video for evaluation.Upon reviewing the video, a crack was observed in the y-site.Retained samples were used for additional evaluation, there were no visual defects noted and all product was manufactured according to specification.It was thought that excessive force by the operator when connecting the connector piece to the y-site could have been a potential cause for this incident.All testing was reviewed for the reported lot, including leakage, torque, and inspection results with no issues identified related to the reported malfunction.Based on available information, we were not able to identify a definitive root cause related to the manufacturing process at this time.
 
Event Description
It was reported that the bd phaseal secondary set (c62) experienced a failure to contain blood/medication prior to use.The following information was provided by the initial reporter: c62 secondary set crack.During priming the secondary set c62 with normal saline, leakages occur at the connection part of the connector with the tubing.Small crack shown at the leaking area.Customer has disposed of said tubing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PHASEAL SECONDARY SET (C62)
Type of Device
STOP COCK
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key9355585
MDR Text Key204284304
Report Number3003152976-2019-00793
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 01/06/2020
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 Date03/31/2023
Device Catalogue Number515312
Device Lot NumberTA11681
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received11/21/2019
Supplement Dates Manufacturer Received11/05/2019
Supplement Dates FDA Received01/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-