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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH P400 PREM U/M 16FR CATH SECURE; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
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CARDINAL HEALTH P400 PREM U/M 16FR CATH SECURE; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE Back to Search Results
Model Number P4P16SD
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  Injury  
Event Description
The customer reported the tip of the catheter was torn off when the catheter was removed from the patient.They stated that upon insertion there was more resistance than normal but did not check the catheter tip.They performed an mri and cat scan to ensure that the catheter was no longer in the patient.Additional information provided by the initial reporter stated that the catheter was not tested prior to use.The catheter was inserted and removed on the same day.At the end of the case, anesthesia reported fairly minimal urine output seen in the foley.Drapes down, rn reported th at the catheter was still secured to the right thigh however upon pulling the catheter portion, it appeared to pull away easily and revealed a foley catheter tip that appeared with a tear/missing pattern at the tip.Ct scan post-op was completed and read negative.Cystoscope was performed and the missing tip was not located.The tip was not found after a thorough search.No further intervention was scheduled or required.
 
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Manufacturer Narrative
Per the initial dhr review of the reported lot number, it was determined that the product model number was reported incorrectly.
 
Event Description
The customer reported the tip of the catheter was torn off when the catheter was removed from the patient.They stated that upon insertion there was more resistance than normal but did not check the catheter tip.They performed an mri and cat scan to ensure that the catheter was no longer in the patient.Additional information provided by the initial reporter stated that the catheter was not tested prior to use.The catheter was inserted and removed on the same day.At the end of the case, anesthesia reported fairly minimal urine output seen in the foley.Drapes down, rn reported th at the catheter was still secured to the right thigh however upon pulling the catheter portion, it appeared to pull away easily and revealed a foley catheter tip that appeared with a tear/missing pattern at the tip.Ct scan post-op was completed and read negative.Cystoscope was performed and the missing tip was not located.The tip was not found after a thorough search.No further intervention was scheduled or required.Additional information received from the reporter on 17-nov-2021 states that originally they thought the tip ripped but after the fact they believe the tip of the catheter above the balloon was missing when opened.
 
Manufacturer Narrative
Updated section b5 describe event or problem to include additional information received from the reporter on 17-nov-2021.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The physical sample was not returned for evaluation however six digital images were provided for review and were visually analyzed.The reported issue was observed; the catheter does not have the tip part.An investigation was requested to the supplier of the affected component as our assembly process only consists in a pick and place operation.Per the supplier, the reported batch was produced in accordance with the procedure and specification.No non-conformities were reported during the production.The batch passed 100% tip inspection, 100% inspection for proper balloon inflation and additional 100% visual inspection after packaging.No rejects for similar failures were reported.The supplier¿s production controls contain at least three points which would discover and reject catheters without a tip.Therefore they concluded that it is highly unlikely that such part would pass all controls and be shipped from their production facility.The root cause was undetermined.At this time, no corrective actions will be required as the reported issue could not be confirmed as manufacturing related.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
 
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Brand Name
P400 PREM U/M 16FR CATH SECURE
Type of Device
DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
Manufacturer (Section D)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
Manufacturer (Section G)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key12821314
MDR Text Key280832410
Report Number9612030-2021-03093
Device Sequence Number1
Product Code FFG
UDI-Device Identifier10884521174061
UDI-Public10884521174061
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberP4P16SD
Device Catalogue NumberP4P16SD
Device Lot Number2120907564
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient SexFemale
Patient Weight82 KG
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