MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42800-39

Device Problem Disconnection (1171)

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

Event Date 11/12/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.However; testing has not yet been completed.

Event Description

The event involved a transpac it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve where the reported stated that the extension that connects the transducer set to the infusion set became disconnected during patient use.The device was used with normal saline.The set up was transducer to alaris tubing.There was a patient involvement and delay in therapy, but no adverse event.

Manufacturer Narrative

Received one used.List #42800-39, transpac¿ it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve; lot #8602165.The reported complaint of a tubing separation was confirmed on the returned set.During visual inspection, the pvc tubing was found separated from the transducer luer pocket.The tubing was microscopically examined and insufficient adhesive coverage was observed on the pvc tubing.The probable cause of the separation had occurred due to insufficient adhesive coverage applied during assembly at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING
• 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: 15974283
• MDR Text Key: 306158181
• Report Number: 9617594-2022-00322
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709098169
• UDI-Public: (01)00887709098169(17)250901(10)8602165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42800-39
• Device Catalogue Number: 42800-39
• Device Lot Number: 8602165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: TUBING, BD ALARIS MFR