MAUDE Adverse Event Report: HALYARD HEALTH, INC. SILVERSOAKER ANTIMICROBIAL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Lot Number 0202825643

Device Problems Difficult to Remove (1528); Component Missing (2306)

Patient Problem Tissue Damage (2104)

Event Date 01/18/2018

Event Type  Injury  

Event Description

Patient had a posterior lumbar decompression laminectomy l2-l3 and l3-l4.After procedure, the circulator informed patient experience officer (peo) of a pull-away sheath tear during surgery.At that time, he noted much resistance and notified the operating room circulator.They then contacted the on-q representative who stated that the distal end of the pull-away sheath may have been punctured when the trocar with sheath in place may have redirected.He mentioned that if it was the case, by removing the catheter within the sheath, the sheath should remove easily.Surgeon was notified regarding this information and gave the okay to remove the catheter and then re-attempt to remove the pull-away sheath.The catheter was removed but the pull-away sheath was still showing resistance.The rep was recontacted and stated that the pull-away sheath may have been inadvertently sutured.When sheath was finally removed, the distal (approximate) 5mm of the white pull-away sheath was missing when compared to an identical pull-away sheath.Surgeon was renotified and pa and lateral radiology films were taken of patient's back.No foreign body was noted on the films as per radiologist.The rep stated that leaving a portion of the catheter in the patient should not cause the patient any problems.Surgeon was notified and asked for a patient to be awoken and brought to recovery and he would notify the family.

• Brand Name: SILVERSOAKER ANTIMICROBIAL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): HALYARD HEALTH, INC. ; 5405 windward pkwy. ; alpharetta GA 30004
• MDR Report Key: 7266608
• MDR Text Key: 100072223
• Report Number: MW5075207
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Lot Number: 0202825643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2018
• 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: 68 YR
• Patient Weight: 120