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
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 first of eight events.
Additional Manufacturer Narrative
Device has been received; however, investigation is still pending.
Additional Manufacturer Narrative
Received one used list #12568, clave¿ neutral connector with lot #5804923 along with two used.Needle hub catheter (manufacturer unknown and lot #unknown) and one used 10ml syringe (list and lot number unknown).Unknown residual observed on the used device and the mating devices.Received 2 photos showing the clave connected attached to a catheter and no damages or anomalies noted.Visual inspection: the used clave connectors were connected to a catheter and no damages or anomalies noted.Functional inspection: the used clave connector and the catheters were hydrostatic pressured leak tested and no leak were observed in the activated and inactivated state.No disconnections noted.No stick downs observed during multiple activation test.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.Also received eighty-two new.List #12568, clave¿ neutral connector; lot #5809423.It is understood that the molding process, automation, and subsequent packing of 12568, clave¿ neutral connector; is random.Therefore, the samples that were sent back were randomly selected as if the whole lot population was available to draw from.Using binomial stages sampling plan (95% confidence, 0.10 ucl, n=0, crc handbook of probability and statistics: second edition) this would allow for thirty-five (35) samples to represent the lot population.Thirty-five of the returned clave were randomly selected as a representative sample for functional testing.Each used clave and the thirty-five (35) was disconnected and pressure leak test (p-3g-376) as per ps00-00037.No leaks observed in the activated and inactivated stated.No disconnections noted.Each clave was submitted to a multiple activation test.The female luer was accessed 96 times with water per ps00-00037 (spec is 96 activations without stick down).No stick downs were observed.Cal id: p-2g-189.The male luer of each clave was measured male luer slip gage: g-1g-157 - all pass the female luer of each catheter mating device was measured: iso female luer taper (g-1g-156, plug gauge): both pass.The returned used clave connectors and the thirty-five (35) samples as a representative of the lot were leak tested per product specification.No leaks observed.
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).

• 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: 14596975
• Report Number: 9617594-2022-00150
• Device Sequence Number: 17506173
• 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