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

Catalog Number 101354

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unreported date in 2022.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a "slight " blood loss occurred during therapy with a y connector s 660 c.The y-shaped branches separated after connecting and inserting the needle into the patient's arm.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.The sample was visually inspected and a crack in the y connector was observed.The reported condition was verified.The cause is supplier related.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: LINE 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 60073 ; 2242702068
• MDR Report Key: 15844444
• MDR Text Key: 304326344
• Report Number: 1416980-2022-06392
• Device Sequence Number: 1
• Product Code: FJK
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 101354
• Device Lot Number: 22G10T301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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