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	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a cath lab w/5 port "off" manifold (600 psi), 72" admin set and 4 ft transpac® iv where it was reported that the manifold was cracked.The event occurred immediately on use in the hospital.There was patient involvement and no patient harm/ injury.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
The reported complaint of cracks was confirmed on sample-2, sample-3, and sample-4 and not confirmed on sample-1 and sample-5.Sample-1: no visual anomalies were observed on the returned samples.The transducers were able to be connected and disconnected to the manifold.When the returned set was primed and pressure leak tested, no leaks were observed.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 out of iso specification female luers had occurred due to error during molding.Sample-2: during visual inspection, the rotating male luer was received separated from the transducer.A crack was observed on the rotating male luer.When the returned set was primed and pressure leak tested, a leak was observed through the crack.The probable cause of the crack 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 out of iso specification female luers had occurred due to error during molding.Sample-3: during visual inspection, one end of the female luer of the manifold was observed to have a crack.No crazing was observed near the crack.The transducers were able to be connected and disconnected to the manifold.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 out of iso specification female luers had occurred due to error during molding.Sample-4: during visual inspection, one end of the female luer of the manifold was observed to have a crack.No crazing was observed near the crack.The transducers were able to be connected and disconnected to the manifold.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 out of iso specification female luers had occurred due to error during molding.Sample-5: no visual anomalies were observed on the returned sample.The transducers were able to be connected and disconnected to the manifold.When the returned set was primed and pressure leak tested, no leaks were observed.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 out of iso specification female luers had occurred due to error during molding.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 5/21/2024.

• 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: 19392226
• Report Number: 9617594-2024-00663
• Device Sequence Number: 12705693
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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