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 Codes	Crack (1135); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a microclave® neutral connector.It was reported that the pump alarmed occlusion during an infusion with an umbilical venous catheter (uvc) infusing total parenteral nutrition (tpn) and intralipid (il).The nurse visually assessed the line to the baby and noticed an unspecified amount of air in the line.It was stated that the clave neutral connector was cracked in the blue clave.The air bubble did not reach the patient and the clave was changed out.There was patient involvement, however no report of patient harm.
Additional Manufacturer Narrative
Device has been received, however investigation has not yet begun.
Event or Problem Description
Additional information received from the customer stating the intravenous (iv) pump began alarming, reading occluded.The nurse visually assessed the line and noticed an in-line air bubble.The nurse attempted to draw back the line unsuccessfully, so line was clamped.The blue clave was replaced with a new clave, and then the nurse was able to draw back the air bubble from line.The iv pump was started again and infused appropriately.The nurse noted a crack in the blue clave.An initial reporter from the medwatch form was provided and it is (b)(6).
Additional Manufacturer Narrative
F2: uf/importer report number: (b)(4).
Additional Manufacturer Narrative
The devices were received for testing on 4/20/2022.Received one new 12568 and one used 12568 microclave connected to a bd 3 ml syringe.A scratch on the surface of the used microclave was observed.The scratch did not penetrate through the housing and would not affect the functionality of the device.Each microclave was tested per product specifications.Both microclaves met design specifications.The reported complaint of the (b)(6) allowing air passage could not be confirmed.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: 14211741
• Report Number: 9617594-2022-00096
• Device Sequence Number: 1819678
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: (01)00887709042377(17)270201(10)5809423
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/31/2022

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: 04/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 07/20/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 05/24/2022; 08/17/2022
• 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: UMBILICAL VENOUS CATHETER, UNK MFR.; UNSPECIFIED INTRALIPID THERAPY, UNK MFR.; UNSPECIFIED TOTAL PARENTAL NUTRITION, UNK MFR.
• Patient Age: 3 DA
• Patient Sex: Female