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

Catalog Number 0600570

Device Problem Material Integrity Problem (2978)

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

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 device has not been returned to the manufacturer for evaluation, as the device remains in the patient.A lot history review (lhr) of huan1659 showed no other similar product complaint(s) from this lot number.

Event Description

As reported by the facility, weak area on red lumen where the hub and reinforced area meet.Layers separated and blood noted between these layers.

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 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 blood between the clamping oversleeve and the extension leg tubing was confirmed and the cause appears to be related to use of the device.The extension leg from what could be a 7fr d/l hickman catheter was returned for investigation.A visual observation of the returned sample revealed that the printing on the clamping oversleeve was completely worn away.Debris was observed within the crevices of the clamp.The extension leg had been cut 1.8 cm from the distal end of the clamping oversleeve and the remainder of the catheter was not returned for investigation.The cross section at the distal end of the catheter segment exhibited a glossy and striated surface, which indicates that the tubing was cut with a sharp instrument.Weakness was detected in the catheter just distal to the red crimp collar.A functional test of the catheter revealed that the lumen with the red luer adaptor was patent to infusion, but under pressure, fluid would fill the space between the clamping oversleeve and the extension leg tubing.No fluid would leak from the catheter.A complete break in the extension leg tubing, which coincided with the luer adaptor stem, was observed after cutting and pulling back the clamping oversleeve.The break allowed fluid to fill the space between the extension leg tubing and the clamping oversleeve.Even though the extension leg was broken, the tubing was constrained within the clamping oversleeve.The outside diameter of the luer adaptor stem showed rounded edges.The missing print from the clamping oversleeve indicates that the catheter may have been clamped or manipulated near the crimp collar.Clamping the catheter near the crimp collar or repeatedly flexing or kinking the catheter in the area can stress the catheter as it is stretched over the luer adaptor barb, eventually leading to catheter failure.The product ifu states, ¿always clamp the catheter over the reinforced clamping sleeve or tape tab, as instructed by your nurse.Never clamp over the reinforced segment directly adjacent to the connector.¿ no damage or defects related to the manufacturing process were noted on the returned sample.

• 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: 6373001
• MDR Text Key: 69167714
• Report Number: 3006260740-2017-00180
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869(17)210128(10)HUAN1659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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 Expiration Date: 01/28/2021
• Device Catalogue Number: 0600570
• Device Lot Number: HUAN1659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1