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

Catalog Number 101354

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported the tubing of a accessory "y" connector was observed detached from the hard plastic arterial connection.It appeared "not welded".No blood or fluid leakage was noted.The event occurred during patient therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The event occurred on an unreported date in 2023.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the device was manufactured on an unspecified date in dec2022.H10: the device was received for evaluation.The sample was visually inspected and a disconnection of the y connector was observed.The reported condition was verified.The cause was due to operator error in the course f the bonding step of the manual assembly during the manufacturing process.Immediate actions such as conduct a training with a photo of the actual returned set to ensure awareness and prevent from similar cases, operators were made aware of the reported non-conformance and were sensitized to safeguard strict adherence to product specifications to ensure this non-conformance would not occur in the future.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; r. de chebbaou; oued ellil 27700 ; TS 27700
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16611963
• MDR Text Key: 312022871
• Report Number: 1416980-2023-01319
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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: 22L21T083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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