MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CHEMO-AIDE DISPENSING PIN; SET, I.V. FLUID TRANSFER

Catalog Number 2N9106

Device Problem Break (1069)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the female luer protective cap of an unspecified quantity of chemo-aide dispensing pins were damaged.This issue was further described as, ¿blue cap that goes with the luer lock in the dispensing pin, inserted to the bag, the blue cap is shredding into the luer lock of the pin¿.This issue was observed during setup prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h4, h6 and h10.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: CHEMO-AIDE DISPENSING PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17414910
• MDR Text Key: 319977484
• Report Number: 1416980-2023-03815
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412035130
• UDI-Public: (01)00085412035130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

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: Other
• Device Catalogue Number: 2N9106
• Device Lot Number: DR23D10062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/28/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/29/2023
• Date Device Manufactured: 04/12/2023
• 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