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: BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC
  • 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
 

BOSTON SCIENTIFIC CORPORATION FLEXIMA; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Model Number 32375
Device Problems Contamination (1120); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Event Description
It was reported that the package seal and the sterility of the device were compromised.A flexima drainage catheter was selected for use.During preparation, the catheter package was ripped open upon taking out of the box.It was noted that the package seal and the sterility of the device were compromised.The procedure was completed with a different catheter.No patient complications were reported.
 
Event Description
It was reported that the package seal and the sterility of the device were compromised.A flexima drainage catheter was selected for use.During preparation, the catheter package was ripped open upon taking out of the box.It was noted that the package seal and the sterility of the device were compromised.The procedure was completed with a different catheter.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The costumer attached a picture of the device, and media inspection was performed.It is possible to observe that the pouch was broken so part of the device was exposed through the pouch.The device and the pouch were returned for the analysis, and visual inspection was performed.It was possible to see that the device returned outside the pouch.Also, the pouch was broken, and it had evidence of wrinkles, so it shows that the pouch was manipulated.The catheter, the flexible cannula and a sheath were returned as part of the device, and no damages were observed.No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FLEXIMA
Type of Device
TUBE, DRAINAGE, SUPRAPUBIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15670518
MDR Text Key306426006
Report Number2124215-2022-42164
Device Sequence Number1
Product Code GBO
UDI-Device Identifier08714729323310
UDI-Public08714729323310
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number32375
Device Catalogue Number32375
Device Lot Number0029513998
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2022
Initial Date FDA Received10/25/2022
Supplement Dates Manufacturer Received11/17/2022
Supplement Dates FDA Received12/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-