MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46115-68
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event involves a transpac® iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush device, macrodrip un-bonded that the customer reported leaking from a bonded site below the transducer during patient use.There was patient involvement but no delay in therapy, no adverse event, and no harm reported.
Additional Manufacturer Narrative
H10: no product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.

• Brand Name: TRANSPAC IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI
• 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: 10488816
• Report Number: 9617594-2020-00369
• Device Sequence Number: 2925574
• Product Code: DRS
• UDI-Device Identifier: 00887709087040
• UDI-Public: (01)00887709087040(17)230601(10)4896331
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 06/01/2023
• Device Catalogue Number: 46115-68
• Device Lot Number: 4896331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1