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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 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.
 
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Brand NameSTAY SAFE/LUER LOCK CATHETER EXT. 12 IN.
Type of DeviceDIALYZER, 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
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
mike allen #1331
parque industrial reynosa
reynosa 88780
MX 88780
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key8203651
MDR Text Key131767075
Report Number8030665-2018-02083
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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
Device Catalogue Number050-95004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/15/2019
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 Reuse

Patient Treatment Data
Date Received: 12/28/2018 Patient Sequence Number: 1
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