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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 050-95004
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
It was reported that a peritoneal dialysis (pd) patient discovered a fluid leak coming from their fresenius catheter extension during their pd treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.Upon follow up, the peritoneal dialysis nurse (pdrn) stated that because the reported event occurred on a sunday (when the clinic is closed), the patient presented to the emergency room (er) to have their catheter extension examined.The patient¿s catheter extension was changed in the er, and the patient was not admitted to the hospital.The pdrn stated that per the clinic¿s procedure the patient was prescribed prophylactic antibiotics (type, dose, route, and course unknown).It was confirmed that despite the prophylactic antibiotics, that there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.It was confirmed that the patient has continued pd therapy as prescribed without further issue.The patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The catheter extension used by the patient was discarded in the er and is not available for return for physical evaluation by the manufacturer.Additional patient, event, and er course information was requested, but was not available.
 
Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius catheter extension sets shipped to this account within the selected time frame.The entire set of lots has been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
 
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Brand Name
STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX  88780
MDR Report Key8203651
MDR Text Key131767075
Report Number8030665-2018-02083
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100781
UDI-Public00840861100781
Combination Product (y/n)N
PMA/PMN Number
K904806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number050-95004
Was Device Available for Evaluation? No
Device Age MO
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER
Patient Outcome(s) Required Intervention;
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