MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET 8MM PRE 2 VENOUS INJECT SITES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2922-7
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility nurse reported a blood leak that occurred at the beginning of the patient¿s hemodialysis (hd) treatment.The blood leak was visually observed at the y-shaped connection of the combi set near the blood pump.The connections were tight.There was no defect or damaged noticed on the combi set.The patient¿s estimated blood loss (ebl) was reported as minimal; a few drops.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with new supplies.The complaint device was discarded and are not available to be returned to the manufacturer for physical evaluation.
Additional 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.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.No information regarding a possible lot number was found there for a review of the device history record could not be performed.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: COMBI SET 8MM PRE 2 VENOUS INJECT SITES
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 8864965
• Report Number: 8030665-2019-01210
• Device Sequence Number: 221509
• Product Code: FJK
• UDI-Device Identifier: 00840861100323
• UDI-Public: 00840861100323
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• 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): 08/15/2019

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 03-2922-7
• Device Lot Number: 19CR01083
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1