MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V; STOPCOCK, I.V. SET

Model Number	B33973
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a 14" (36 cm) appx 3.6 ml, transfer set w/4 clave, 2 tri-connectors, back check valve, clamp (blue), vented capwhich was reported to have leaked during chemotherapy infusion on a patient.The reporter stated that one of the connectors just pops up, loose and was not connecting and a leak was noted.It was not reported whether or not there was unprotected exposure to the chemotherapy.No harm was reported as a consequence of this event.
Additional Manufacturer Narrative
One used 4" (36 cm) appx 3.6 ml, transfer set w/4 clave¿, 2 tri-connectors, back check valve, clamp (blue), vented cap was received for evaluation.No visual anomalies were observed as received.The complaint of leakage can be confirmed on the returned unit.The set was leak tested pre product specification.There was a leak observed from one of the y-clave from in-between the adapter and the semi rigid bonding pocket.Each of the microclave/adapters on the used sets were tested for bond integrity.The y-clave that leaked separated below specification.The separated adapter was examined.There appeared to be solvent observed on the adapter.However, the bonding pocket appeared to only have solvent on one side.The probable cause of the leakage and separation observed is due to insufficient solvent coverage applied during manual assembly at the manufacturing site.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 14" (36 CM) APPX 3.6 ML, TRANSFER SET W/4 CLAVE¿, 2 TRI-CONNECTORS, BACK CHECK V
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15714558
• Report Number: 9617594-2022-00294
• Device Sequence Number: 4800988
• Product Code: FMG
• UDI-Device Identifier: 00887709123984
• UDI-Public: (01)00887709123984(17)270401(10)5916735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: B33973
• Device Catalogue Number: B33973
• Device Lot Number: 5916735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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 CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown