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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peritonitis (2252)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a temporal relationship exists between the pd therapy with the fresenius pd extension set and the patient¿s peritonitis. However, there is no objective evidence that a fresenius pd extension set malfunction or product deficiency was associated with this event. The patient¿s peritonitis can be reasonably attributed to a breach in aseptic technique as it was reported the patient was not capping the pd catheter end after pd treatment and reused the fresenius extension set against instructions for use.
 
Event Description
It was reported that a patient was admitted to the hospital for peritonitis. Upon follow up with the pdrn, it was reported that the patient contaminated the pd catheter end by not capping the pd catheter end after pd treatment and was reusing the fresenius extensions set against instructions for use. As a result, the pd nurse obtained a pd effluent culture in the outpatient pd clinic on (b)(6) 2019 which yielded an elevated white blood cell (wbc) count of 561. The patient was treated on an outpatient basis with cefazolin 1 gram and ceftazidime 1 gram intra-peritoneal (ip) for 21 days. The patient recovered fully from this event. The pdrn stated the patient was re-educated multiple times on not reusing the extension set and using a pd catheter cap at the end of very treatment.
 
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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.
director, quality systems
1100 e. military hwy., suite c
pharr TX 78577
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key9185632
MDR Text Key162369180
Report Number8030665-2019-01584
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
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received10/11/2019
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: 10/14/2019 Patient Sequence Number: 1
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