MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	852-011-46104-58
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with a transpac iv monitoring kit, stating that the tubing and cap were dislodged before priming.There was no patient involvement and no patient harm.Testing was performed on the returned device the reported problem was confirmed.An image was provided by the customer showing the area of the defect.However, the returned sample does not match with the image provided.During visual inspection, the 12.5" pressure tubing was found separated from the male luer.The pressure tubing was found tacky at the bond site.The probable cause of the pressure tubing being tacky had occurred due to the solvent on the tubing not being fully cured during assembly process.A lot review was performed and there were no issues found.

• Brand Name: TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC
• Common Device Name: 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
• MDR Report Key: 12217091
• Report Number: 9617594-2021-00205
• Device Sequence Number: 14579768
• Product Code: DRS
• UDI-Device Identifier: 00840619097424
• UDI-Public: (01)00840619097424(17)230801(10)4960664
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 852-011-46104-58
• Device Lot Number: 4960664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1