MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. HICKMAN 9 F DUAL-LUMEN CV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600604

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 11/29/2019

Event Type  Injury  

Event Description

From staff: patient with hickman catheter implanted by surgeon.A month later, per operative note, hickman required repair by surgeon secondary to rupture of catheter lumen.7 months later, patient seen at an outside facility with bleeding from hickman and noted rupture of catheter lumen by emergency department (ed) physician.Ed physician spoke with covering surgeon and was instructed on removal of catheter.

Event Description

I found that there was a rupture of the smaller lumen at the most proximal end of the common channel.This was immediately adjacent to the confluence of the dual lumens.This gave me enough external length to perform an external repair of the catheter without full replacement of the catheter.Distal to the rupture i transected the common channel cleanly and then used the 9 french dual-lumen hickman catheter repair kit to complete the external repair.Once i had the repair complete i was able to gently aspirate blood through both lumens and both were easily flushed with gentle pressure with no evidence of leaking.The repaired segment was splinted with a tongue depressor and the catheter and repaired segment was secured to the patient's chest.The patient tolerated this procedure well and did not require any anesthetic.No imaging was performed.At completion the patient was taken to the recovery area in satisfactory condition.Findings: rupture of catheter lumen at proximal end of common channel adjacent to confluence of dual lumens.

• Brand Name: HICKMAN 9 F DUAL-LUMEN CV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 9457625
• MDR Text Key: 170453451
• Report Number: 9457625
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0600604
• Device Catalogue Number: 0600604
• Device Lot Number: HUCX2855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 22630 DA
• Patient Weight: 119