MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. SINGLE NEEDLE BLOOD TUBING SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number	SINGLE NEEDLE BLOOD TUBING SET
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
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 home hemodialysis patient reported to a fresenius canadian technician that a bloodline leaked from the y-connector at the top of the arterial chamber.The date of the event was not provided in the initial reporting.It was reported that the leak was found at the beginning of treatment; however, an estimated blood loss (ebl) volume was not provided.The sample was reported to be available for a manufacturer evaluation.No further details were given.Multiple attempts were made to obtain additional information, however, to date a response has not been received.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However, a photograph of the blood tubing set connected to the machine was provided by the customer.Evidence of a blood leak was apparent in the provided photograph.The photograph shows blood leaking at the arterial monitor line, where the y-connector is adjoined to the luer lock.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformance's 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.The reported event was confirmed based on the provided photograph; however, a cause for the issue could not be established.
Event or Problem Description
A home hemodialysis patient reported to a fresenius canadian technician that a bloodline leaked from the y-connector at the top of the arterial chamber.The date of the event was not provided in the initial reporting.It was reported that the leak was found at the beginning of treatment; however, an estimated blood loss (ebl) volume was not provided.The sample was reported to be available for a manufacturer evaluation.No further details were given.Multiple attempts were made to obtain additional information, however, to date a response has not been received.Additional follow-up revealed that the sample was discarded, and therefore, no longer available to be returned for evaluation.

• Brand Name: SINGLE NEEDLE BLOOD TUBING SET
• 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: 10578170
• Report Number: 8030665-2020-01394
• Device Sequence Number: 3208531
• Product Code: FJK
• UDI-Device Identifier: 00840861100286
• UDI-Public: 00840861100286
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2020

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: 11/30/2021
• Device Model Number: SINGLE NEEDLE BLOOD TUBING SET
• Device Catalogue Number: 03-2696-7
• Device Lot Number: 18PR01813
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/05/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1