MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SURPLUG EXTENSION TUBE 2" (5CM), ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 066-C3072

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the returned device a comprehensive investigation cannot be performed.If additional information becomes available, a supplemental report will be submitted.

Event Description

The user reported that a black foreign object was inside the product.

Manufacturer Narrative

H10: no product samples were returned for investigation, however, a photograph was provided and evaluated.A 066-c3072 assembly was shown and a black foreign piece was confirmed in or on the male luer threads.It cannot be determined from the photo if the foreign is encapsulated or loose in the treads.The source of the foreign cannot be determined from the photograph.The dhr (device history review) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The probable cause of the black foreign piece cannot be determined with the photos and information provided.

• Brand Name: SURPLUG EXTENSION TUBE 2" (5CM), ROTATING LUER
• 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
• MDR Report Key: 9732921
• MDR Text Key: 198540576
• Report Number: 9617594-2020-00050
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619084301
• UDI-Public: (01)00840619084301(17)230801(10)3750682
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

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: 08/01/2023
• Device Catalogue Number: 066-C3072
• Device Lot Number: 3750682
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1