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 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

It was reported that a transpac iv monitoring kit tubing was found separated once the package was opened.There were no other defects noted on the product.The product was replaced and therapy resumed.There was no patient involvement and no patient harm.No further information is available.

Manufacturer Narrative

The reported complaint of tubing separation was confirmed on the returned set.During visual inspection, the 12" pressure tubing was received and separated from the female luer.Insufficient adhesive coverage was observed on the tubing pocket.The separation of the bond was due to insufficient adhesive coverage on the pressure tubing.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during assembly.Additional information - d9 - date returned to mfg 11/7/2022.

• 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: 15731448
• MDR Text Key: 303435499
• Report Number: 9617594-2022-00295
• Device Sequence Number: 1
• Product Code: DRS
• 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,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

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 Catalogue Number: 886-42584-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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