MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ZYTOMED-VERABREICHUNGS-SET ONKO II; STOPCOCK, I.V. SET

Catalog Number SN1205A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/04/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a zytomed-verabreichungs-set onko ii where a cytostatic ran over the hand of the nurse when handling an unspecified medication to be infused.This occurred when disconnecting the spinning spiros of the onko set (sn(b)(4)) from the list number (b)(4), the spinning spiros came loose from the luerlock connection of the onko set.There was no patient involvement and no patient harm noted.This is the first of four events reported.

Manufacturer Narrative

Received one used list #sn1205a, zytomed-verabreichungs-set onko ii; lot #4096749, two used unknown infusions sets, and one chemoclave bag spike (unknown list and lot#) and were visually inspected.As received, the spiros of list #sn1205a add-on set was disconnected from the male luer adapter.Per the product design configuration for list #sn1205a the spiros should be bonded to the male luer adaptor.Little to no solvent was present on the disconnected components.No other damage or anomalies were identified.The reported complaint can be confirmed.The probable cause is due to an error during manual assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 5/12/2022.E1 - initial reporter phone: (b)(6).

• Brand Name: ZYTOMED-VERABREICHUNGS-SET ONKO II
• 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: 14317737
• MDR Text Key: 299846528
• Report Number: 9617594-2022-00115
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619050276
• UDI-Public: (01)00840619050276(17)220501(10)4096749
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: SN1205A
• Device Lot Number: 4096749
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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: ANSTECHDORN MIT BELÜFTUNG UND CLAVEL#O036B ICU MFR.; UNSPECIFIED CYTOSTATIC MEDICATION, MFR UNK.