MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK ADAPTER 4 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
Event or Problem Description
A follow up call with a peritoneal dialysis (pd) patient¿s nurse revealed the patient was hospitalized from (b)(6) 2017 to (b)(6) 2017 due to peritonitis while completing manual treatment.The patient¿s effluent culture showed no growth and the white blood cell was 26019 (units unknown).The patient was treated with vancomycin and ceftazidime (route and dose unknown).On (b)(6) 2017, a repeat culture was performed and the white blood count was 7304 (units unknown).The cause of the peritonitis was suspected to be a breach in aseptic technique due to a leak at the adapter connection.The patient was reported to have recovered from the peritonitis event.
Additional Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.There were no nonconformances 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: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 6909113
• Report Number: 8030665-2017-00796
• Device Sequence Number: 711433
• Product Code: KDJ
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95003
• Device Lot Number: 17ER08138
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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: DELFLEX FLUID
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention