MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	Z3626
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is not yet received.
Event or Problem Description
The event involved a 129" (328 cm) appx 16.6 ml, 15 drop primary set w/2 clave¿, remv 4-way stopcock w/clave¿, spin luer, 2 ext where the customer reported that the tubing is poor quality and have been cracking and leaking when in use.There was unknown patient involvement; harm was not reported as a consequence of this event.And unknown harm.Ilapitan 28-may-2024.Gcm received an email on 24-may-2024 from david reyes, complaint coord i of medline industries, lp with regard to a 129" (328 cm) appx 16.6 ml, 15 drop primary set w/2 clave¿, remv 4-way stopcock w/clave¿, spin luer, 2 ext with item number z3626 and lot number 13875905.It was reported that the customer has received tubes that are poor quality.The tubes have been cracking and leaking when in use.There was unknown patient involvement and unknown harm.Ilapitan 28-may-2024.
Additional Manufacturer Narrative
Additional information: the device was not returned for evaluation.The complaint of cracks on item z3626 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.Lot history review was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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 drive; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19584424
• Report Number: 9617594-2024-00791
• Device Sequence Number: 7326889
• Product Code: FPA
• UDI-Device Identifier: 00887709034082
• UDI-Public: (01)00887709034082(17)290101(10)13875905
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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 Catalogue Number: Z3626
• Device Lot Number: 13875905
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sex: Unknown