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

Catalog Number H938174

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a cut on the tubing of a vented high-volume inlet device.This issue was identified detected opening the package.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Upon further due diligence, "after opening the sterile outer packaging a crack/defect was detected".No leak occurred.Two devices were received for evaluation.Visual inspection was performed which observed that the tubing was kinked; however, no other damage was observed.The reported condition 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 60073 ; 2242702068
• MDR Report Key: 9863752
• MDR Text Key: 184420820
• Report Number: 1416980-2020-01614
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475790
• UDI-Public: (01)00085412475790
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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 Expiration Date: 08/01/2021
• Device Catalogue Number: H938174
• Device Lot Number: 802717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/22/2020
• Supplement Dates Manufacturer Received: 04/14/2020
• Supplement Dates FDA Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1