MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED LUER; NOT PROVIDED

Catalog Number UNKNOWN

Device Problem Separation Problem (4043)

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

Event Date 05/25/2023

Event Type  malfunction  

Event Description

The event involved an unspecified luer where the reporter stated an issue that the luer comes off during infusion.The identity of the involved and /or mating device is a prefilled syringe.That the drug involved is heparin sodium.There was patient involvement, unknown patient harm and no delay in critical therapy.

Manufacturer Narrative

The complaint of separation can be confirmed on the returned one used, list #unknown, luer extension set; lot #unknown.As received the tubing was separated from the male luer.The tubing and male luer were examined.The tubing appeared to have sufficient solvent on the tubing.However, the end of the tubing is at an angle as if a portion of the tubing is missing.The male luer had insufficient solvent in the bonding pocket.It is unknown if this is the correct male luer for the returned tubing.No list number or lot number were reported to verify configuration.The probable cause of the separation is unknown.Additional contact: (b)(6).

• Brand Name: UNSPECIFIED LUER
• Type of Device: NOT PROVIDED
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17603514
• MDR Text Key: 321742077
• Report Number: 9617594-2023-00588
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• 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: HEPARIN SODIUM, MFR UNK; PREFILLED SYRINGE, MFR UNK