MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 ANSTECHDORNE MIT BELÜFTUNG UND CLAVE®; STOPCOCK, I.V. SET

Catalog Number O036B-5

Device Problem Fluid/Blood Leak (1250)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however it has not yet been received.Initial reporter phone: (b)(6).

Event Description

The device involved is a 5 anstechdorne mit belüftung und clave.The cap and the filter of the vented spike adapter fell out during the administration of chemotherapy contaminating the nurse.There was no medical or surgical intervention required.The device was changed out/replaced with no further problems encountered.There is no patient involvement, no serious injury/death and no blood loss.This captures the second of two incidents.

Manufacturer Narrative

Received one used list #o036b-5, 5 anstechdorne mit belüftung und clave® with lot #5498909.The returned device did not have any visible damage or anomalies and was pressure tested with the cap closed and opened.No leakage was observed, and the filter vent assembly remained intact.The lot history was reviewed, and no nonconformities identified that may have contributed to the reported complaint.Additional information: d9 - date returned to mfg is 5/12/2022.

• Brand Name: 5 ANSTECHDORNE MIT BELÜFTUNG UND CLAVE®
• Type of Device: STOPCOCK, I.V. SET
• 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: 14315886
• MDR Text Key: 291219480
• Report Number: 9617594-2022-00113
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619067663
• UDI-Public: (01)00840619067663(17)260701(10)5498909
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K082836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: O036B-5
• Device Lot Number: 5498909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED INFUSION PUMP, MFR UNK