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

Catalog Number	011-C3300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Four brand-new samples list#011-c3300 and one new, bd plastipak 10 ml syringe were returned for evaluation.As received no physical damage, anomalies or gaps between the blue body and spike were observed.The iso dimensional test of the male luers and the syringe were measured and met the iso design specifications.Complaint of separation was not able to be confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a clave¿ neutral connector where it was reported the blue component was coming apart from the body of the connector, rendering it unusable and meaning the bung had to be replaced.The status of the product at time of event was during infusion during induction of a patient undergoing general anesthesia.There was no serious injury, no blood loss, no unprotected chemo exposure, adverse operator consequences, and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.The customer stated the clear plastic bungs seem a courser casting and seem prone to be cross threaded.They used to the opaque mat blue bungs which can cross thread too, but the clear ones seem easier to cross thread.They have never previously been able to remove the body of the bung while un-attaching a syringe.The medication involved in the event is only intravenous (iv) hartmanns.There was patient involvement and unknown patient harm.

• Brand Name: MICROCLAVE® 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: 18702969
• Report Number: 9617594-2024-00152
• Device Sequence Number: 12310739
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)280701(10)13700453
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2024

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: 011-C3300
• Device Lot Number: 13700453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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: BD SYRINGE LL STERILE; UNSPECIFIED ANESTHETIC, UNK MFR
• Patient Sex: Unknown