MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	46100-91
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved a cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv.The reporter stated that the stopcock cracked off immediately upon patient use at the hospital.There was no patient harm/injury as a result of the complaint/event.
Additional Manufacturer Narrative
The reported complaint of stopcock cracked was confirmed.During visual inspection, one end of the female luer of the manifold observed to have a crack.No crazing was observed near the crack.When the returned set was primed and pressure leak tested, a leak was observed from the crack on the female luer of the manifold.The probable cause of the crack on the female luer is unknown.The male luers of the transpac and the female luers of the manifold were dimensionally inspected and the extreme end of the female luers of the manifold failed the iso slip luer gage inspection.The probable cause of is a molding error during manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 21may2024.

• Brand Name: CATH LAB W/5 PORT "OFF" MANIFOLD (600 PSI), 72" ADMIN SET AND 4 FT TRANSPAC® IV
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 19348477
• Report Number: 9617594-2024-00629
• Device Sequence Number: 7280695
• Product Code: DQO
• UDI-Device Identifier: 00840619070601
• UDI-Public: (01)00840619070601(17)260601(10)13672865
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K932141
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 46100-91
• Device Lot Number: 13672865
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 05/19/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown