MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INLET, MICROVOL,VENTED SPIKE,; SET, I.V. FLUID TRANSFER

Catalog Number H938751

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a hair was identified inside the packaging of a micro-volume inlet.This issue was identified while checking the packaging integrity, prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured between february 10, 2020 to february 11, 2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye which revealed that a hair like string was observed inside the packaging.The reported condition was verified.  by the nature of the sample, no additional tests could be performed. therefore, the cause of the condition could not be 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: INLET, MICROVOL,VENTED SPIKE,
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11581478
• MDR Text Key: 245938993
• Report Number: 1416980-2021-01657
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477299
• UDI-Public: (01)00085412477299
• Combination Product (y/n): Y
• PMA/PMN Number: K903159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: H938751
• Device Lot Number: 60226090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1