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: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM; STOPCOCK
  • 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
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM; STOPCOCK Back to Search Results
Catalog Number 394926
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
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 an unspecified number of connectas wht 360deg tb 25cm experienced tubing separation from adapter/luer connection.Product defect was noted during use.The following information was provided by the initial reporter: each time you flush the access from the extension cord, it disconnects from the proximal connection to the venous access.Leakage of the infusion with dispersion and contamination of the drug.
 
Event Description
It was reported that an unspecified number of connectas wht 360deg tb 25cm experienced tubing separation from adapter/luer connection.Product defect was noted during use.The following information was provided by the initial reporter: each time you flush the access from the extension cord, it disconnects from the proximal connection to the venous access.Leakage of the infusion with dispersion and contamination of the drug.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9193077.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: a device history record review was performed for provided lot number 9193077.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this incident, one physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, the adapter component was observed separated from the tubing.It has been determined that this separation was a result of partial adhesive solvent between the two components, which would also result in leakage.A quality alert has been raised in response to this incident.
 
Event Description
It was reported that an unspecified number of connectas wht 360deg tb 25cm experienced tubing separation from adapter/luer connection.Product defect was noted during use.The following information was provided by the initial reporter: each time you flush the access from the extension cord, it disconnects from the proximal connection to the venous access.Leakage of the infusion with dispersion and contamination of the drug.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONNECTA WHT 360DEG TB 25CM
Type of Device
STOPCOCK
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9963052
MDR Text Key195317099
Report Number9610847-2020-00135
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 foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 07/31/2020
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 Date06/30/2022
Device Catalogue Number394926
Device Lot Number9193077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2020
Initial Date Manufacturer Received 03/26/2020
Initial Date FDA Received04/15/2020
Supplement Dates Manufacturer Received03/26/2020
03/26/2020
Supplement Dates FDA Received05/06/2020
07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-