MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12568
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) used.List #12568, clave¿ neutral connector; lot #unknown.One (1) used.List #unknown, extension tubing; lot #unknown.No visual damages or anomalies were observed.The male luer and female luer were iso tested and found to be within specifications.A leak test was performed and no leaks were observed.The reported complaint of the microclave disconnection could not be replicated or confirmed.The returned sample was tested and performed to product specifications.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.
Additional Manufacturer Narrative
The lot# is unknown resulting in unknown expiration and manufacturing dates.The device has been received, but an investigation is not yet completed.When complete, then a supplemental mdr will be submitted.
Event or Problem Description
A complaint regarding a microclave® neutral connector experienced disconnection.The report stated that the claves becomes detached from extension set.Nursing noticed that the threads in the clave are not matching/gripping to the extension set.It was not detected prior to direct patient use.Involved mating device is medline extension tubing.There was no blood loss and unprotected chemo exposure.There was no adverse operator consequences.The device was changed out/replaced with no further problems encountered and the involved device available to be tested.There was patient involvement, no adverse event or patient harm and no delay in therapy.

• Brand Name: MICROCLAVE® NEUTRAL CONNECTOR
• 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 dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20251394
• Report Number: 9617594-2024-01311
• Device Sequence Number: 15494746
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: 00887709042377
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K970855
• 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): 10/30/2024

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: 12568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED DRUG , MFR UNK.; UNSPECIFIED EXTENSION SET, MFR UNK.
• Patient Sex: Unknown