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

Catalog Number B3300

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 02/03/2024

Event Type  malfunction  

Event Description

The event involved a clave¿ neutral connector where leaking of fluids and fosphenytoin medication from microclave connector was reported.They inspected and found to be cracked.The tubing was changed, and medication was re-dosed.There was patient involvement but no patient harm and there was a delay in administering medicine.

Manufacturer Narrative

Received one used list #b3300 clave with an unknown extension set.The clave came in with a stick down.The spike was observed to come through the seal and tearing was observed on the seal.Unknown residuals were observed on the stick down.Upon disassembly the seal was found to have tearing not only on the top of the seal but down the side as well.No damage or anomalies seen on the body.No mating device was returned for evaluation.The complaint of medication leaking from microclave connector can be confirmed due to the stick down found.The probable cause of the stick down is typical of use with an incompatible mating device.The direction for use (dfu) states, "users should confirm mating luers or syringes have an internal diameter range of 0.062¿ to 0.110¿ ".A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: CLAVE¿ 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: 18866100
• MDR Text Key: 337483907
• Report Number: 9617594-2024-00244
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2024

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: B3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: FOSPHENYTOIN, MFR UNK; UNSPECIFIED FLUIDS, MFR UNK