MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT

Model Number 011-46103-94

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2017

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not been received.

Event Description

The customer reported that when unpacking a transpac® iv monitoring kit w/safeset it was discovered that the extension tube was disconnected from the valve.A review of the sample pictures provided by the customer appears to show that the separation is located at a bonded site.

Manufacturer Narrative

One (1) unused transpac iv set with lot# 3438195 was evaluated.The 27" red striped pressure tubing was separated from the male luer.The end of the tubing with the uv adhesive was tacky and showed signs that the adhesive was not cured.A pull test was completed on the female luer on the other end of the 27" pressure tubing and passed specifications.A device history review (dhr) was completed and no non-conformities were noted.Icu medical, through continuous improvement initiatives, have initiated a multi-discipline task team and reviewed the assembly process of this part.Subsequent to the initial medwatch report, manufacturing site was updated to reflect the legal manufacturing address instead of the address of the contact office.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Type of Device: TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7222961
• MDR Text Key: 98539435
• Report Number: 9617594-2018-00005
• 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: 02/21/2018

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
• Device Operator: Pharmacist
• Device Expiration Date: 04/01/2020
• Device Model Number: 011-46103-94
• Device Catalogue Number: 011-46103-94
• Device Lot Number: 3438195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 02/05/2018
• Supplement Dates FDA Received: 02/21/2018
• Patient Sequence Number: 1