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
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem 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 third of three reports.
Additional 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).
Additional Manufacturer Narrative
The b3 - date of event was updated from 12dec2023 to (b)(6) 2023.
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation -a picture showing a microclave detached from the tubing.The picture confirms the general complaint of device detachment.A sample #3 (for the third occurrence of this complaint) was not returned to the manufacturer for complaint investigation.Without the return of the third sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history of the provided lot number was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Updated information can be found in d9.

• Brand Name: EXT SET, SMALLBORE TRIFUSE WITH 3 CLAVE¿
• Common Device Name: 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: 18342199
• Report Number: 9617594-2023-01168
• Device Sequence Number: 8424696
• Product Code: FMG
• UDI-Device Identifier: 00840619001773
• UDI-Public: (01)00840619001773(17)250701(10)4922392
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K964435
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 07/01/2025
• Device Catalogue Number: 011-C3323
• Device Lot Number: 4922392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 12/28/2023; 04/05/2024
• Initial Report FDA Received Date: 12/17/2023
• Supplement Report FDA Received Date: 01/23/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TPN, MFR UNK
• Patient Sex: Unknown