MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GAMBRO BLOODLINE ACCESSORIES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 101354

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported that three (3) accessories y connector s 660 c did not connect properly on the dialysis line.No leaks were reported to have occurred.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction d9: the correct sample receipt date was november 17, 2021.H10: the device was received for evaluation.The sample was visually inspected and a detachment of the screw cap from the set was observed.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GAMBRO BLOODLINE ACCESSORIES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - TUNISIA; route de chebbaou km 12; oued ellil 2021 tunsia; oued ellil 2021 ; TS 2021
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12863366
• MDR Text Key: 282970787
• Report Number: 1416980-2021-06950
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 07332414004699
• UDI-Public: (01)07332414004699
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K801016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 101354
• Device Lot Number: 20L22T714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1