MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1339
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 8" ext set with 0.2 micron filter, clamp, rotating luer.It was stated in the report that the client was receiving chemotherapy and she noticed that something was wet on the armrest.They stopped infusions to find out where the leak was and found that the rigid plastic tube had come out of the center of the filter that was on the paclitaxel line.The medication on the affected line had already been infused, flushed and the line clamped about 45 minutes prior.At the time of the incident, it had been running normal saline only, at (b)(4).There colleague assisted with the cleanup of the spilled normal saline and desk nurse was made aware.The affected line was removed.The other chemotherapy line was not affected.There was patient involvement, no patient harm and unknown delay in infusion.
Additional Manufacturer Narrative
One (1) used.List #b1339, 8" was returned for evaluation.As received the tube was separated from the inlet filter and some marks indicating that solvent was applied and marks on the filter as well.The complaint of leaks can be confirmed based on the returned physical sample.The probable cause of the separation is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19813263
• Report Number: 9617594-2024-00927
• Device Sequence Number: 8780816
• Product Code: FMG
• UDI-Device Identifier: 00887709001190
• UDI-Public: (01)00887709001190(17)281201(10)13861539
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Catalogue Number: B1339
• Device Lot Number: 13861539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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: NORMAL SALINE, MFR UNK; PACLITAXEL/ TAXOL, MFR UNK
• Patient Sex: Unknown