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

Model Number	12568
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been received; however, investigation is still pending.
Event or Problem Description
The event occurred on unspecified date in april of 2022 involving a microclave® neutral connector where it was reported that the hub of the iv is falling off/apart, and an air embolism was identified on computed tomography (ct) on the peripheral site.There was patient involvement but no patient harm.No additional information was provided.This is the fifth of eight events.
Event or Problem Description
Received additional informational on 21-jun-2022 stating the facility confirmed priming of microclave and luering on tightly.The customer also stated that in the computed tomography (ct) area, when doing biopsy, they use an extension set (item number 12517-01 from icu med) and syringe kit (item number sss-ctp-qft from medrad stellant).They typically connect angicath directly to microclave.The doctor prefers this method as it creates consistent pressure.They also used flush syringe (item number 306546 from bd).
Additional Manufacturer Narrative
Received eighty-two new clave¿ neutral connector with list #12568 and lot #5809423.Thirty-five of the returned samples were randomly selected as if the whole lot population was available to draw from for functional testing.The samples were disconnected, and pressure leak tested.No leaks observed in the activated and inactivated state.There were no disconnections noted.No stick downs observed during multiple activation test.Received 2 photos showing the clave connected attached to a catheter and no damages or anomalies noted.The complaint of separation could not be confirmed or replicated.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14596996
• Report Number: 9617594-2022-00153
• Device Sequence Number: 2095526
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: (01)00887709042377(17)270201(10)5809423
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/09/2022

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 Model Number: 12568
• Device Catalogue Number: 12568
• Device Lot Number: 5809423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: EXTENSION SET ITEM #12517-01, ICU MED MFR.; FLUSH SYRINGE ITEM #306546, BD MFR.; SYRINGE KIT ITEM #SSS-CTP-QFT, MEDRAD STELLANT MFR.; UNSPECIFIED IV PRODUCT, MFR UNK.
• Patient Sex: Unknown