MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 886-42584-05

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Event Description

The event involved a transpac iv monitoring kit where it was reported that the tubing was separated from 3-way stopcock below the chip.The solution used was normal saline.There were no other defects noted on the product.The product was replaced, and therapy was resumed.There was no patient involvement and no patient harm.No additional information was provided.

Manufacturer Narrative

The device is available for evaluation.The investigation has not begun.

Manufacturer Narrative

Received one used.List #886-42584-05, transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip; lot #4975464.The reported complaint of tubing separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the 48.5" pressure tubing was found separated from the female luer.The pressure tubing was found tacky at the bond site.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during assembly process at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - date returned to mfg is 10/28/2022.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 15674148
• MDR Text Key: 307167826
• Report Number: 9617594-2022-00292
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619068615
• UDI-Public: (01)00840619068615(17)230801(10)4975464
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 886-42584-05
• Device Lot Number: 4975464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORMAL SALINE SOLUTION, MFR UNK