MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE TRANSPAC® IT MONITORING KIT W/ 104" RED STRIPE TUBING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	011-0J729-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.However, samples of the same list/lot are available for return; however, they have not yet been received.D4, g4: model number is not sold in the us but similar device is sold under model number 42801-27.This product's model number was used for the di and 501k.
Event or Problem Description
The complaint/event involved a single transpac® it monitoring kit w/ 104" red stripe tubing.It was reported that the tubing disconnected downstream from the tap after blood sampling.The patient was connected to the device at the time of the reported disconnection.There was some blood loss, but without serious clinical consequences.There was no delay in critical therapy, and no need of medical intervention.The tubing was replaced with a new set from the same list number.There was no visible default on the device before use.No cuts, no tears and no holes were observed on the device.There was no report of human harm.
Additional Manufacturer Narrative
The reported complaint of separation was not confirmed on the returned (new, unused) set.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, no leaks were observed.The product had performed per the specifications.Without the return of the reported sample, the complaint could not be confirmed.D9 - date returned to mfg: 26sep2024.

• Brand Name: SINGLE TRANSPAC® IT MONITORING KIT W/ 104" RED STRIPE TUBING
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19982411
• Report Number: 9617594-2024-01135
• Device Sequence Number: 14143394
• Product Code: DRS
• UDI-Device Identifier: 00887709120761
• UDI-Public: 00887709120761
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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 Catalogue Number: 011-0J729-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown