MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO; STOPCOCK, I.V. SET

Catalog Number B33895

Device Problems Break (1069); Crack (1135)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, however, investigation is not yet complete.

Event Description

The event involved a 107" (272 cm) transfer set w/dual check valve, microclave®, luer lock which the customer reported breakage of the hard plastic portion of the microclave.The customer reported that the product was in use at the time of malfunction, thus there was patient involvement; harm was not reported as a consequence of this event.

Manufacturer Narrative

One (1) used sample list #b33895 was returned for evaluation.As received a broken section on the thread section of the microclave and some beach marks and crazing marks suggesting environment stress during use were observed.The missing part was not returned for evaluation for evaluation.No mating device was returned.Complaint of cracks can be confirmed based on the used physical sample evaluation.The probable cause is typical due to environmental stress during use.The lot review could not be conducted because no lot number(s) was/were identified.

• Brand Name: 107" (272 CM) APPX 8.7 ML, TRANSFER SET W/DUAL CHECK VALVE, MICROCLAVE®, LUER LO
• 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: 18271880
• MDR Text Key: 329777019
• Report Number: 9617594-2023-01076
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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: Health Professional
• Device Catalogue Number: B33895
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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