MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PFHA STERILE LUER LOCK TIPCAP; DISPENSER, LIQUID MEDICATION

Catalog Number H93865001

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

It was reported that a luer lock tip cap had a foreign object sealed in the package.The issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The user facility submitted medwatch mw5122981 for this event.E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h4, h6, and h10: h4: the lot was manufactured between august 10, 2023 ¿ august 11, 2023.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PFHA STERILE LUER LOCK TIPCAP
• Type of Device: DISPENSER, LIQUID MEDICATION
• 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: 17860835
• MDR Text Key: 324799123
• Report Number: 1416980-2023-04974
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 00085412478821
• UDI-Public: (01)00085412478821
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H93865001
• Device Lot Number: 60387916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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
• Treatment: NA.