MAUDE Adverse Event Report: MEDSOURCE MEDSOURCE

Model Number MS-83092

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  malfunction  

Event Description

Inadequate/unglued/unsealed connection between the extension tubing and male luer lock adapter.Iv fluids leak, and tubing may easily separate from adapter.Medsource ms-83092 8" (20cm) needless extension set.Lot # 1500740.Mfg date 201701.Exp date 202112.Personnel discovered the defective product while preparing the iv administration set, prior to patient contact.Specifically, the defect was discovered while priming the tube with normal saline.This same defect had been reported on a previous encounter by another employee, however it had been misunderstood.It was believed the employee was reporting leaking around the upper female adapter valve, which can be disconnected.The employee in the prior incident was advised to verify the female adapter valve is securely fastened to the tubing prior to use.After the above occurrence, the employee from the prior occurrence reaffirmed that leaking was experienced between the tubing and male luer lock adapter.While removing the product from our inventory, we discovered some older product.The older product had identification markings of: lot 1500640.Mfg date 201609.Exp date 202109.A cursory test of this older/other lot did not reveal the defect.

• Brand Name: MEDSOURCE
• Type of Device: MEDSOURCE
• Manufacturer (Section D): MEDSOURCE; chaska MN 55318
• MDR Report Key: 6728260
• MDR Text Key: 80663804
• Report Number: MW5071099
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: MS-83092
• Device Lot Number: 1500740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 127