MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. LIFESHIELD MICROBORE EXTENSION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	0269428
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the oncology unit has experienced leaking from their 0.2-micron filter tubing.It was indicated that it was specifically leaking from the filter.Their current practice is changing the tubing/filter after day 2 of administration.There were no issues noted during the initial priming/set-up of the set.It is unknown if the chemotherapy being used came in contact with the patient but unfortunately, some chemo was wasted because of the leaks.She confirmed that the chemo spill was cleaned up per facility protocol.There was no harm to the patient reported.No additional information is available.This is report 3 of 3.
Additional Manufacturer Narrative
The actual sample was discarded, however, the customer returned one new unused lifeshield microbore extension from the same lot.The set was tested per product specification and no leakages were observed.The reported complaint of leakage was unable to be replicated or confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: LIFESHIELD MICROBORE EXTENSION
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15191264
• Report Number: 9615050-2022-00168
• Device Sequence Number: 5541895
• Product Code: FPA
• UDI-Device Identifier: 10887787005018
• UDI-Public: (01)10887787005018(17)231101(10)5082408
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 0269428
• Device Catalogue Number: 2694-28
• Device Lot Number: 5082408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMO MEDICATION, UNK MFR
• Patient Sex: Unknown