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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 208360581
• Report Number: 8030665-2020-01394
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100286
• UDI-Public: 00840861100286
• Combination Product (y/n): N
• PMA/PMN Number: K000451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 10/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1