MAUDE Adverse Event Report: MEDLINE MEDLINE CONTINUOUS EPIDURAL CATH; EPIDURAL CATHETER

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

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

Event Date 03/15/2016

Event Type  Other  

Event Description

Medline (brand name) continuous epidural catheter kinked during labor, thus rendering the indwelling catheter useless for delivery of analgesic drugs.Had the patient needed to have a c section, the epidural would have had to been replaced entirely or another type of anesthesia used.Is the product compounded: no.Is the product over the counter: no.

• Brand Name: MEDLINE CONTINUOUS EPIDURAL CATH
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): MEDLINE
• MDR Report Key: 5541498
• MDR Text Key: 41722612
• Report Number: MW5061409
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Patient Weight: 79