MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" (25 CM) RED STRIPE TUBING W/NEEDLELESS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46111-48

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for investigation.It is not yet complete.

Event Description

The event occurred on an unknown date.The event involved a 10" (25 cm) red stripe tubing w/needleless valve that the customer reported disconnecting at a glued point.The customer also stated the same set also had a plunger malfunction where the black rubber component within the reservoir is stuck and has detached from the pull-back component.There was patient involvement and delay in therapy, however, no report of patient harm.

Manufacturer Narrative

H10: received one used list# 011-46111-48, 10" (25 cm) red stripe tubing w/needleless valve.Lot # 4361158.The reported complaint of arterial line separation was confirmed.The list and lot number of the plunger connected to the zeroing stopcock of the red stripe tubing was not provided.During visual inspection, the 10" pressure tubing was found separated from the female luer of the red stripe tubing.The bond surface of the pressure tubing was found tacky.A pull test was conducted on a representative uv bonds, between the pressure tubing and the male luer.The tubing broke near the luer above the specifications limit.The probable cause of the tubing separation had occurred due to the uv adhesive at the bond between the arterial tubing and the female luer was not fully cured.This defect was due to a manual manufacturing error.A device history review (dhr) lot# 4361158 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 10" (25 CM) RED STRIPE TUBING W/NEEDLELESS VALVE
• 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: 9751439
• MDR Text Key: 198545254
• Report Number: 9617594-2020-00054
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619079185
• UDI-Public: (01)00840619079185(17)220901(10)4361158
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 011-46111-48
• Device Lot Number: 4361158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1