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

Catalog Number	050-95003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.In addition, there is no information with the customer number reported, at this time no sap shipping search could be performed with the information available.Consequently, no product will be returned from the distribution center to be analyzed since the lot number is unknown and no information from the customer is available for the identified of the possible involved lots in sap.There was no device history record (dhr) review was performed since the lot number is unknown and no information from the customer is available.
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported that the connector to the baxter was loosened and a fluid leak occurred.The patient stated that they hang their bag on the side of the cart and that there is a flaw in the connector, possibly the baxter end.The patient begun taping the connector so that it does not open.Additional information was requested, however, to date not provided.
Event or Problem Description
A peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) reported that the connector to the baxter was loosened and a fluid leak occurred.The patient stated that they hang their bag on the side of the cart and that there is a flaw in the connector, possibly the baxter end.The patient begun taping the connector so that it does not open.The nurse stated that the patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient completed treatment on the cycler.The patient is continuing peritoneal dialysis therapy with no further issues.The patient was not symptomatic and was not treated with antibiotics.

• 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: 9368460
• Report Number: 8030665-2019-01787
• Device Sequence Number: 2866822
• Product Code: FKX
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K822550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95003
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 12/05/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/04/2019; 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 95