MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV TRIFURCATED MONITORING KIT 84", 3 DISPOSABLE TRANSDUCERS WITH 2 STO; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-42590-08

Device Problem Separation Failure (2547)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a transpac® iv trifurcated monitoring kit, 84" 3 disposable transducers with 2 stopcocks 3 3 ml squeeze flushes, macrodrip (pole mount) which was reported to have snapped off near the stopcock.There was no patient involvement and no harm reported as a consequence of this event.

Manufacturer Narrative

One open/unused transpac® iv trifurcated monitoring kit, 84" 3 disposable transducers with 2 stopcocks 3 3 ml squeeze flushes, macrodrip (pole mount) was received for evaluation.The reported complaint of defective product was confirmed on the returned set.During visual inspection, the transducer of the proximal tubing was observed to be broken.Bleach marks were observed on the transducer and the broken male luer of the transducer.The probable cause on the breakage of the male luer of the transducer had occurred due to unintentional bending forces applied during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV TRIFURCATED MONITORING KIT 84", 3 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: 15770772
• MDR Text Key: 308019164
• Report Number: 9617594-2022-00298
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-42590-08
• Device Lot Number: 6023936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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