MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VENTED HIGH VOL. INLET, N/S; SET, I.V. FLUID TRANSFER

Catalog Number H938174

Device Problem Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Initial reporter city: créteil.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vented high-volume inlet had "air intake".The set was noted to be kinked "about 4 cm from the distal termination of the tubing" when removed from the packaging.This was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Unaided visual inspection was performed which observed a damaged kinked tubing near the connector inlet.Functional testing was performed with sterile water installed on the main module and no leak or air was observed.No other defect was observed.The reported condition of air in intake was not verified.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: VENTED HIGH VOL. INLET, N/S
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLASTICOS Y MATERIAS PRIMAS PYMPSA; 3609-2 juan de la barrera; parque industrial el alamo; guadalajara, jalisco 44490 ; MX 44490
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15254070
• MDR Text Key: 302281508
• Report Number: 1416980-2022-04334
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H938174
• Device Lot Number: 803207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• 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