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

Catalog Number	12512-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a microclave¿ clear neutral connector where the customer reported that the intravenous (iv) tubing was leaking during patient use in the emergency room - sru.The customer further reported difficulty in connecting or tightening the connectors of the device, which resulted in the leakage.There was evidence of leakage observed beneath the tagaderm sticker used to cover the iv and connector.The data was collected by the staff er apex ct scanner; there was no repeat test performed.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.Possible lot number: 13701450.Manufacturing date: 07/11/2023.Expiration date: 07/01/2028.
Additional Manufacturer Narrative
A few photos were shared by the customer, where an icu medical set #12514-01 and unknown bd devices are observed, both are on a sealed package in an additional photo a sealed item #12512-01, microclave is observed as well.However, no damage, anomalies, or issues are observed.The complaint of leaks on item 12512-01 cannot be confirmed.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The device history review (dhr) couldn't be performed due to the lot number for this complaint was unknown.

• Brand Name: MICROCLAVE¿ CLEAR 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; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19899203
• Report Number: 9617594-2024-01053
• Device Sequence Number: 17744736
• Product Code: FPA
• UDI-Device Identifier: 00887709050532
• UDI-Public: 00887709050532
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• 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): 08/22/2024

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 Catalogue Number: 12512-01
• Device Lot Number: UNKNOWN
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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