MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IV BIFURCATED KIT MONITORING, 72" 2 DISPOSABLE TRANSDUCERS, WITH 2 STO; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 886-42500-19

Device Problem Material Separation (1562)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

The event involved a transpac iv monitoring kit which was reported to have separated tubing observed during priming.There was no other defects noted on the product.There was no patient involvement and no harm reported as a consequence of this event.

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Manufacturer Narrative

One transpac¿ iv bifurcated kit monitoring, 72" 2 disposable transducers, with 2 stopcocks, 2 3ml squeeze flush device, macrodrip (pole mount) were received for evaluation.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 pvc tubing was found separated from the winged male luer.The tubing was microscopically examined and insufficient solvent was observed on the pvc tubing.The probable cause of the separation had occurred due to insufficient solvent applied during assembly in manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IV BIFURCATED KIT MONITORING, 72" 2 DISPOSABLE TRANSDUCERS, WITH 2 STO
• 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: 15781160
• MDR Text Key: 307793838
• Report Number: 9617594-2022-00299
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619068608
• UDI-Public: (01)00840619068608(17)250201(10)5834338
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 886-42500-19
• Device Lot Number: 5834338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2022
• 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, MFR UNK