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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, UPPER URINARY TRACT
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DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. FOLEY CATHETER WITH TEMPERATURE SENSOR; CATHETER, UPPER URINARY TRACT Back to Search Results
Model Number BS81-080412
Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)
Patient Problem Discomfort (2330)
Event Date 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating a foley catheter with temperature sensor (part bs81-080412) failed during use.The end user was unable to remove water from the catheter balloon prior to device removal, resulting in some bleeding and discomfort to patients.The defective sample was discarded and unable to be returned for evaluation.A review of the device history record showed no discrepancies that may have contributed to the reported problem.A representative sample from the suspected lot that was reported in the complaint was not available.Therefore, raw material catheters from other lots were tested at the manufacturing facility.Testing was performed by filling the catheter balloon with saline and removing it.All balloons inflated and deflated with no issues.The silicone portion of the catheter is manufactured by degania silicone.Therefore, a supplier corrective action request was issued to (b)(6) on june 4, 2018.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
 
Event Description
The nursing staff inserted the catheter, and 3mls of water were inserted into the balloon.Staff was unable to remove water prior to removal.The balloon had to be deflated after piercing with wire.Two instances of this were reported.In one instance, the end user stated the event caused bleeding when the device was removed without being deflated.In the other instance, the patient experience discomfort and leapt from the bed.The staff inserted a guidewire to deflate the device and it was removed without further intervention.
 
Manufacturer Narrative
Root cause: because the silicone portion of the catheter is manufactured by degania silicone, a supplier corrective action request was issued to degania.In its response, degania indicated the returned raw material parts were inflated and deflated successfully, and the batch history review did not reveal any discrepancy.The batches passed 100 percent balloon check, which includes inflation and deflation.The customer complaint could not be confirmed.Corrective action: because the complaint could not be confirmed, a corrective action was not taken.Investigation summary an internal complaint (call 44302) was received indicating a foley catheter with temperature sensor (part bs81-080412) failed during use.The end user was unable to remove water from the catheter balloon prior to device removal, resulting in some bleeding and discomfort to patients.The defective sample was discarded and unable to be returned for evaluation.A review of the device history record showed no discrepancies that may have contributed to the reported problem.A representative sample from the suspected lot that was reported in the complaint was not available.Therefore, raw material catheters from other lots were tested at the manufacturing facility.Testing was performed by filling the catheter balloon with saline and removing it.All balloons inflated and deflated with no issues.The customer's report could not be confirmed.The silicone portion of the catheter is manufactured by degania silicone.Therefore, a supplier corrective action request was issued to degania on june 4, 2018.The completed scar was returned july 17, 2018.Deroyal returned 100 unused raw material pieces in their original packaging to degania.These returned pieces were from the same raw material batch as the raw material utilized in the affected finished good lot.These raw material pieces were evaluated by degania.Review of sales and similar complaint information showed the following: 1) deroyal has sold 65 cases or 3,250 each of finished good bs81-080412 from may 2016 to present and 2) during the review period, a total of one complaint (the one associated with this report) was received for this product.This equates to a complaint to sales ratio of 0.015 percent.Deroyal will continue to monitor post market feedback and will recognize in the future if a trend develops.Preventive action: because the complaint could not be confirmed, a preventive action was not taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.
 
Event Description
The nursing staff inserted the catheter, and 3mls of water were inserted into the balloon.Staff was unable to remove water prior to removal.The balloon had to be deflated after piercing with wire.Two instances of this were reported.In one instance, the end user stated the event caused bleeding when the device was removed without being deflated.In the other instance, the patient experience discomfort and leapt from the bed.The staff inserted a guidewire to deflate the device and it was removed without further intervention.
 
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Brand Name
FOLEY CATHETER WITH TEMPERATURE SENSOR
Type of Device
CATHETER, UPPER URINARY TRACT
Manufacturer (Section D)
DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.
global park
box 180-3006, 602 parkway
la aurora, heredia, heredia 146
CS  146
MDR Report Key7652462
MDR Text Key113009211
Report Number2320762-2018-00003
Device Sequence Number1
Product Code EYC
UDI-Device Identifier00749756878937
UDI-Public0749756878937
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 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBS81-080412
Device Lot Number40866001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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