MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE TP IT KIT BELGIUM W/SAFESET AND CVP LINE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0J961-01

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Lot no: possible lot number 4417945 (manufactured date 11/1/2019).The device is not available for evaluation.

Event Description

The event occurred on an unknown date.The customer reported that the safest weld connection near the syringe spontaneously come loose where the stopper in the syringe comes loose when they retract.The device was changed out/replaced with no further problems encountered.There was no serious injury/death or delay in critical therapy, but there was patient involvement and blood loss.

Manufacturer Narrative

H10: no product sample(s) were returned and no photographs or videos were provided for investigation.Therefore a comprehensive failure investigation was unable to be performed.A device history review (dhr) lot# 4417945 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: SINGLE TP IT KIT BELGIUM W/SAFESET AND CVP LINE
• 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
• MDR Report Key: 9772641
• MDR Text Key: 203137081
• Report Number: 9617594-2020-00056
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-0J961-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1