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

Catalog Number 12568

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 337188667
• Report Number: 9617594-2024-00242
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: (01)00887709042377(17)281001(10)13778312
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PERIPHERALLY INSERTED CENTRAL CATHETER, UNK MFR; PRIMARY TUBING SET, BD; TOTAL PARENTERAL NUTRITION, UNK MFR