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	04/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a fluid leak was identified coincident with peritoneal dialysis therapy.The peritoneal dialysis registered nurse (pdrn) reported that the adapter used for the solution bag disconnected and solution leaked during treatment.The patient did not develop any symptoms, adverse events, or injuries as a result of the reported event.The patient was given ceftazidime and cefazolin intraperitoneally prophylactically.The pdrn stated that the patient was able to continue pd therapy with no further issues.Should additional information become available, the file will be reassessed and updated accordingly.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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: 7531637
• Report Number: 8030665-2018-00733
• Device Sequence Number: 1512835
• Product Code: FKX
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K822550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2018

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
• Device Lot Number: 17NR08111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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: PD SOLUTION
• Patient Age: 53 YR
• Patient Weight: 90