MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. KOMPLETT-SET 8S PULT LANG; STOPCOCK, I.V. SET

Catalog Number S80800PL

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for testing.It is yet to be received.

Event Description

The customer reported a brown particle inside the front of the plunger of a komplett-set 8s pult lang device.The device was changed out with no further problems encountered.There was no patient involvement and no adverse event.

Manufacturer Narrative

H10: additional information in g1.H11: due to system limitations, g4 was inadvertently submitted as (b)(6) 2019 in the previously submitted follow up 1 under manufacturer report number 9617594-2019-00194-01.The correct date is (b)(6) 2019.

Manufacturer Narrative

H10: one (1) unused partial set list # s80800pl, komplett-set 8s pult lang was received on july 22, 2019.A small piece of brown foreign material was observed in a 50ml bd syringe that was returned out of package.The small particle was analyzed and there were no good matches identified.The customer complaint is confirmed.When or where the small brown particle was introduced into the barrel of the out of package 50ml bd syringe is not known.The device history review for lot 3731054 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: KOMPLETT-SET 8S PULT LANG
• 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: 8735743
• MDR Text Key: 149232600
• Report Number: 9617594-2019-00194
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619065423
• UDI-Public: (01)00840619065423(17)210701(10)3731054
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2019

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: 07/01/2021
• Device Catalogue Number: S80800PL
• Device Lot Number: 3731054
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 05/27/2019; 08/06/2019
• Supplement Dates FDA Received: 08/15/2019; 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1