MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOS; INFUSOR, PRESSURE, FOR I.V. BAGS

Device Problems Leak/Splash (1354); Insufficient Flow or Under Infusion (2182)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/10/2022

Event Type  Injury  

Manufacturer Narrative

Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.D5: operator of device is unknown.E4: initial reporter also sent report to fda is unknown.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.

Event Description

It was reported that the product was leaking and giving the patient high dose of pressor.This was causing patient's blood pressure deterioration.No medical or surgical intervention was reported.

• Brand Name: MEDEX STOPCOCKS INFUSION EXTENSION SETS AND DISPOS
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16797005
• MDR Text Key: 313842218
• Report Number: 3012307300-2023-04453
• Device Sequence Number: 1
• Product Code: KDZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other