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	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for evaluation.It has not been received.
Event or Problem Description
The event occurred on an unspecified date and involved a transpac iv monitoring kit that disconnected between the tubing and the 3-way connector.There was no patient involved and no adverse event reported.
Additional Manufacturer Narrative
Date returned to mfg - june 30, 2020 one used list# 852-011-46104-58, transpac® iv monitoring kit, 72", disposable transducer, 3 ml squeeze flush, macrodrip (pole mount), lot# 4132149 was received for evaluation.The reported complaint of disconnection was confirmed on the returned set.During visual inspection, the 60" pressure tubing was found separated from the male luer and the female luer.The tubing was found tacky on both the ends.The probable cause of the 60" pressure tubing being tacky is due to the tubing not being fully cured during assembly process at ensenada.A representative bond was pulled and the tubing broke near the luer within the specifications.A device history review (dhr) for lot# 4132149 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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: 10189221
• Report Number: 9617594-2020-00196
• Device Sequence Number: 16370768
• Product Code: DRS
• UDI-Device Identifier: 00840619097424
• UDI-Public: (01)00840619097424(17)220601(10)4132149
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 06/01/2022
• Device Catalogue Number: 852-011-46104-58
• Device Lot Number: 4132149
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1