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

Catalog Number H938175

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the tip of one vented micro-volume inlet appeared discolored.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added: the actual sample and a photograph was received for evaluation.A visual inspection was performed to the actual sample which observed a damaged tubing and the spike was missing.The photograph underwent visual inspection which revealed discoloration on the tip of the hose.The reported condition was verified.The cause of the condition was not 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: VENTED MICRO VOL.INLET, N/S
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9552780
• MDR Text Key: 173793767
• Report Number: 1416980-2019-07387
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475806
• UDI-Public: (01)00085412475806
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/04/2022
• Device Catalogue Number: H938175
• Device Lot Number: 802814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• 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