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

Catalog Number	12568
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a clave¿ neutral connector where it was reported during patient infusion of total parenteral nutrition (tpn), the microclave spun or popped off the male luer at the distal end of the bd primary tubing set.The microclave was connected to the end of the peripherally inserted central catheter (picc) line where they would normally have it.This caused a leaking issue and concern for the vascular team.There was patient involvement, no adverse event and no one was harmed as a result of the reported event.
Additional Manufacturer Narrative
One new sample (b)(6) was returned for evaluation.As received no physical damage or anomalies were observed.No mating device was returned for evaluation.The sample was tested as per procedure finding no internal or external leaks after test.The male luer iso meet product design specification.Without the return of the set or mating device complaint cannot 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18864245
• Report Number: 9617594-2024-00242
• Device Sequence Number: 15527503
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: (01)00887709042377(17)281001(10)13778312
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: 12568
• Device Lot Number: 13778312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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: PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR; PRIMARY TUBING SET, BD; TOTAL PARENTERAL NUTRITION, UNK MFR
• Patient Sex: Unknown