MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 0600570

Device Problems Defective Component (2292); Material Integrity Problem (2978)

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

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the healthcare professional (hcp) confirmed that the catheter was coming off the junction part.The hcp suspected that there was a possibility that the junction part of the catheter might have a bonding defect, judging from the status of the catheter which slipped off.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a catheter coming apart is confirmed, but the cause of the event remains unknown.The sample returned consisted of four photographs of components of a hickman-style catheter wrapped in what appeared to be plastic packaging material.Visual observation of the photographs found that two terminations of the product were shown, one being a tube and the other being a bifurcation hub, with two extension legs on the other side.The termination of the tubing showed a smaller diameter tubing within the larger outer tubing.This end of the tubing appeared to show some grayish discoloration.The end of the bifurcation was not obviously irregular.The cause of the separation of the catheter from the bifurcation cannot be determined from the sample returned.Potential causes of this event include tensile breakage, possibly occasioned by inadequate securement, and sharp instrument damage.The ifu states the following: ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth edged atraumatic clamps or forceps.¿ ¿9.Secure catheter at exit site with a sterile dressing.The external segment of the catheter should be coiled and taped.Avoid tension on the catheter segment to prevent dislodging the catheter.¿ a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the healthcare professional (hcp) confirmed that the catheter was coming off the junction part.The hcp suspected that there was a possibility that the junction part of the catheter might have a bonding defect, judging from the status of the catheter which slipped off.

• Brand Name: HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7117015
• MDR Text Key: 95066404
• Report Number: 3006260740-2017-02227
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600570
• Device Catalogue Number: 0600570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 1 YR