MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 050-95005

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2019

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¿s catheter extension set became disconnected from the catheter and fluid leaked during drain three of their pd treatment.The patient clamped the catheter line and contacted the on-call nurse.The patient did not completed treatment.The patient went to the clinic the following day to check the catheter extension set.The patient was able to continue pd therapy with no further issue.The patient stated that they did not experience any symptoms, injuries, adverse events, or require medical intervention as a result of the reported event.The extension set was not available to be returned to the manufacturer for evaluation.

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.No information was found related to possible lot number from product 050-95005.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.

• Brand Name: STAY SAFE/LUER LOCK CATHETER EXT. 18 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 Key: 8493030
• MDR Text Key: 141448714
• Report Number: 8030665-2019-00558
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100798
• UDI-Public: 00840861100798
• Combination Product (y/n): N
• PMA/PMN Number: K904806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-95005
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY SELECT CYCLER