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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL CIENTIFIC DE LATINOAMERICA S.R.L. FOLEY CATHETER, 400 SERIES 14 FR; CATHETER, UPPER URINARY TRACT
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DEROYAL CIENTIFIC DE LATINOAMERICA S.R.L. FOLEY CATHETER, 400 SERIES 14 FR; CATHETER, UPPER URINARY TRACT Back to Search Results
Model Number BS81-080414
Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2020
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received for a catheter that leaked from the balloon and slid out of the patient.The investigation is ongoing a this time.This report will be updated when new and critical information is received.
 
Event Description
Catheter was inserted into the patient.On inserting water into the retention balloon, the fluid was observed leaking from the urethral meatus and the catheter slid out.On testing after removal, the catheter was seen to have a leak in the balloon.10mls of water was used.It was not inserted into the catheter with any force, and there was no resistance.Procedure was delayed as another catheter had to be inserted to continue with the procedure.The catheter was being inserted into the patient to use as a temperature probe.
 
Manufacturer Narrative
Root cause: the silicone catheter device component is supplied to deroyal by xeridiem.Therefore, a supplier corrective action request (scar) was issued to xeridiem.In its response, the supplier stated that a definitive root cause could not be determined due to the absence of a defective sample for evaluation.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint (call 50470) was received for a catheter (part bs81-080414) that leaked from the balloon and slid out of the patient.A sample was not returned for evaluation.However, photos of the defective device were provided.The work order for the affected lot was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.A scar and the photo were sent to xeridiem.A response was received august 24.Follow up was conducted and additional information was received from xeridiem on november 16.A total of 1,350 of reported lot has been sold.However, only 1 catheter from that lot was reported to have malfunctioned.A total of 19,750 cases of the finished good have been sold since july 2018.During this period, only one complaint was received for the finished good part.Deroyal will continue to monitor post-market feedback and will recognize int he future if a trend develops.The investigation is complete at this time.If new and critical information is received, this report will be updated.
 
Event Description
Catheter was inserted into the patient.On inserting water into the retention balloon, the fluid was observed leaking from the urethral meatus and the catheter slid out.On testing after removal, the catheter was seen to have a leak in the balloon.10mls of water was used.It was not inserted into the catheter with any force, and there was no resistance.Procedure was delayed as another catheter had to be inserted to continue with the procedure.The catheter was being inserted into the patient to use as a temperature probe.
 
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Brand Name
FOLEY CATHETER, 400 SERIES 14 FR
Type of Device
CATHETER, UPPER URINARY TRACT
Manufacturer (Section D)
DEROYAL CIENTIFIC DE LATINOAMERICA S.R.L.
box 180-3006, 602 parkway
la aurora
heredia, heredia 146
CS  146
MDR Report Key10367699
MDR Text Key201878583
Report Number2320762-2020-00002
Device Sequence Number1
Product Code EYC
UDI-Device Identifier00749756045773
UDI-Public00749756045773
Combination Product (y/n)N
PMA/PMN Number
K041416
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBS81-080414
Device Lot Number51021135
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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