MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK ADAPTER 4 IN.; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	STAY SAFE/LUER LOCK ADAPTER 4 IN.
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is a possible temporal relationship between the pt¿s staphylococcus epidermis peritonitis and a likely breach in the dialysate pathway when the pt.Experienced a fluid leak between the baxter icodextran bag and the fresenius stay safe luer lock adaptor.Manufacturer product investigation is still pending at the time of this clinical investigation.Therefore, it is unknown if the stay safe luer lock adaptor did or did not perform according to specifications and a possible causal or contributory relationship cannot be ruled out.Should additional information become available, this clinical investigation will be updated accordingly.A supplemental mdr will be submitted upon device evaluation.
Event or Problem Description
A peritoneal dialysis nurse reported the patient experienced a male connection site leak on their apd luer-lock adaptor.The nurse reported that the patient had draining issues and cloudy effluent.The nurse reported the patient was treated for peritonitis.The patient was not hospitalized.The patient is recovering and continuing with peritoneal dialysis therapy.The liberty cycler set was discarded.
Additional Manufacturer Narrative
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 safe lock apd luer lock connectors shipped to this account within the selected time frame.The entire set of lots have 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.

• Brand Name: STAY SAFE/LUER LOCK ADAPTER 4 IN.
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 7412212
• Report Number: 8030665-2018-00519
• Device Sequence Number: 19034162
• Product Code: FKX
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K822550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: STAY SAFE/LUER LOCK ADAPTER 4 IN.
• Device Catalogue Number: 050-95003
• Device Lot Number: 17LR08102
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIBERTY CYCLER; PD SOLUTIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 70