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

Catalog Number	01C-C3300
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial report came through: (b)(6).The investigation on the device and photos have begun, but has not yet been completed.Upon completion, a supplement mdr will be written and submitted.
Event or Problem Description
An event a microclave¿ connector experienced foreign matter in the fluid path.The reporter stated, ¿the picc was connected to 01c-c3300 infusion, and the picc was blocked on the third day.Infusion cannot continue after replacement of infusion joint.The nurse pulled out and examined the picc and found a foreign object in the picc, which was clear and elastic and suspected to be part of 01c-c3300." it was stated in the report that the event was not detected prior to direct patient use.The event occurred during infusion with picc as mating device involved.The device was used for 48 hours.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no adverse operator consequences and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.There is 1 involved problematic device that is available to be tested and being returned for investigation.There was patient involvement, no patient harm and no delay in critical therapy.Update: the customer sent icu medical additional sample photos confirming the foreign matter.
Additional Manufacturer Narrative
A series of photos were shared by customer, where a small transparent particulate is observed over a piece of paper, however no icu medical device is observed.A piece of tape with a small transparent piece of plastic and a white piece of plastic with something stuck inside the id of what appears to be part of #01c-c3300, microclave¿ connector and a new unknown, extension set w/ filter were returned for evaluation.As received, no additional defects or anomalies were observed in the returned sample and / or in the returned mating device.Bonding sides of the mating device met product design specification.The small transparent piece and the white piece of plastic were sent for a ftir study, finding no correlation between them.However, the small transparent piece of plastic has a 94.98% consistency with silicone polydimethylsiloxane.Complaint of cannot continue infusion due to an elastic foreign object suspected cannot be replicated because no functional test was possible to perform due to just a partial device was returned.The probable source of the small transparent piece of plastic cannot be determined without the whole set and the used mating device.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 19974420
• Report Number: 9617594-2024-01119
• Device Sequence Number: 20947560
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)281201(10)13847696
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 01C-C3300
• Device Lot Number: 13847696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• 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
• Patient Sex: Unknown