MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 3-WAY STOPCOCK W/2 NEEDLELESS VALVES AND 03 ML SYRINGE; STOPCOCK, I.V. SET

Catalog Number 46111-61

Device Problem Backflow (1064)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation, but has not been tested yet.

Event Description

The customer reported that a 3-way stopcock w/2 needleless valves was leaking.It was further described that when the nurse was preparing to draw from the device, the blood was backing up into zeroing port and was leaking.There was patient involvement, but no adverse event or delay in critical therapy.

Manufacturer Narrative

One used sample was received for evaluation.Internal blood residuals were observed on the middle stopcock and the blue lav valve was observed to be leaking.The valve was microscopically examined and slit tearing was observed.The internal leak of the stopcock could not be replicated.The complaint of leakage was confirmed.The probable cause of the seal tearing of the lav can not be determined without the return of the mating device.The lot review couldn't be performed due to unknown lot number.

• Brand Name: 3-WAY STOPCOCK W/2 NEEDLELESS VALVES AND 03 ML SYRINGE
• 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: 8918169
• MDR Text Key: 198330027
• Report Number: 9617594-2019-00281
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K080077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

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 Catalogue Number: 46111-61
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 09/16/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1