MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC9013
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B5.The other instance mentioned in b5 which occurred on october 18 was captured mdr mfr# 9617594-2024-01594.Investigation summary received one (1) new mc9013 ext set w/0.2 micron filter for inspection.No defects or anomalies noted.The set was leak tested per product specifications.There was no leakage.The reported complaint could not be replicated or confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
A complaint was received involving a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer that experienced leakage.The problem was: leaking filter in the oncology unit.It was explained that a second identical incident occurred with mc9013 during chemo administration with the same patient on october 20 (previously happened on 18 october).Both affected filters were discarded.They have removed all filters with lot # 13893262 from the hematology-oncology unit.The set up was: mc9013 was added to the usual primary tubing (bbraun (b)(4)- their ¿chemo line¿.The end of mc9013 was attached to the lowest y port on the usual primary tubing (bbraun (b)(4) - their ¿mainline¿ for hydration.There was no hole, cut, tears or any defect noted.She has a couple samples sister from the same lot number available for evaluation.She provided 1 sample photo from the 18 october incident.The sample photo showed fingers holding the filter with liquid leak and like a white cloth with leak on.There was patient involvement and no patient harm.(b)(6) 23 october 2024.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE¿ CLEAR, 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20754313
• Report Number: 9617594-2024-01654
• Device Sequence Number: 8393105
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: 00887709039391
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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: MC9013
• Device Lot Number: 13893262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2024
• 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: PRIMARY TUBING, (B)(4) BBRAUN
• Patient Sex: Unknown