MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE TRIFUSE WITH 3 CLAVE¿; STOPCOCK, I.V. SET

Catalog Number 011-C3323

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

The complaint/event involved a ext set, smallbore trifuse with 3 clave¿.The clave was reported to have detached from the tubing during infusion of total parental nutrition (tpn).The reporter stated that the complaint/issue was causing patients to be at risk for blood loss, infection and/or loss of essential treatment.The remaining batch inventory stock was been removed and replaced with a new batch.No current incidents have been recorded since the switch.The issue was not detected prior to direct patient use.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no adverse operator consequences and no medical/surgical intervention required.The customer reported an unspecified delay in critical therapy.The current status of the patient is 'returned to baseline condition'.There was not any holes, cuts or defects noted on the medical device and the tubing was not reprocessed/re-sterilized.The device was changed out/replaced with no further problems encountered.This record reflects the second of three reports.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Section e initial reporter full phone number: (b)(6).

Manufacturer Narrative

The b3 - date of event was updated from (b)(6) 2023 to (b)(6) 2023.

Manufacturer Narrative

The following was returned (or provided) by the customer for complaint investigation -sample #2 (of 2) used list #011-c3323, ext set, smallbore trifuse with 3 clave¿.-a picture showing a microclave detached from the tubing.The housing on the sample #2 used return device was noted to be a different color than sample #1 indicating they may be from different lots.Sample 2 was received with one microclave separated from the tubing.Iridescent solvent was likely not used on sample 2.No evidence of solvent was observed.The complaint of the clave detaching from the tubing can be confirmed.The probable cause of the detachment on sample 2 is due to a solvent application error during manufacturing.The lot history of the provided lot number was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 16feb2024.

• Brand Name: EXT SET, SMALLBORE TRIFUSE WITH 3 CLAVE¿
• Type of Device: STOPCOCK, I.V. SET
• 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: 18342193
• MDR Text Key: 331062916
• Report Number: 9617594-2023-01167
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619001773
• UDI-Public: (01)00840619001773(17)250701(10)4922392
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C3323
• Device Lot Number: 4922392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TPN, MFR UNK.