MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 1.0 ML, ADAPTADOR UNIVERSAL PARA SISTEMAS IV CON SPIROS®; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number 034-H2629

Device Problem Disconnection (1171)

Patient Problem Chemical Exposure (2570)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, it has not been received.

Event Description

The event occurred on unknown date in (b)(6).The customer reported that 1.0 ml, adaptador universal para sistemas iv con spiros disconnected and leaked vinblastine during infusion.The drug did not come into contact with the patient but the nurse that was attending was exposed.The area was washed per protocol and a spill kit was used.The nurse experienced nausea, vomits, asthenia and diarrhea.This is report 2 of 2.

Manufacturer Narrative

Date returned to mfg: 10/21/2019.Received one new device.The sample was pressure leak tested and no leakage was observed at any location along the bag spike adapter.The bond between the spinning spiros and the small bore was visually inspected and there was sufficient solvent present at the bond.The complaint of disconnection and leakage could not be confirmed.The lot review was performed and there were no issues found.

• Brand Name: APPX 1.0 ML, ADAPTADOR UNIVERSAL PARA SISTEMAS IV CON SPIROS®
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9204330
• MDR Text Key: 187694781
• Report Number: 9617594-2019-00347
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00840619079383
• UDI-Public: (01)00840619079383(17)240301(10)3994816
• Combination Product (y/n): N
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 034-H2629
• Device Lot Number: 3994816
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VINBLASTINE