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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

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 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 ballooning during infusion could be confirmed based on the evidence found on the returned sample.The cause was determined to be related to use of the device.The external segment of a hickman type catheter was returned for investigation.The tubing extended 12 mm from the distal end of the clamping oversleeve.The distal segment of the catheter was not returned for investigation.The printing on the clamping sleeve was partially worn near the crimp collar.The printing in the ¿clamp here¿ region was worn.An impression from clamping remained in the tubing 12 mm proximal to the ¿clamp here¿ region, which indicative of clamping outside the ¿clamp here¿ area.A breach in the circumferential direction was located within the inner layer of tubing that coincided with the distal tip of the luer adaptor stem.It appears that the inner layer of tubing wore against the luer adaptor stem.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 catheter should never be clamped over the reinforced segment directly adjacent to the connector.The breach would have allowed fluid to fill the space between the clamping sleeve and the inner tubing and lead to ballooning of the clamping sleeve.No damage or defects related to the manufacturing process were noted on the returned sample.The damage appears to be associated with use of the device.A lot history review (lhr) of huas1655 showed no other similar product complaint(s) from this lot number.

Event Description

As reported by the facility, clinical area called to advise white lumen would not flush and they saw the white line balloon during flushing.Tpa was placed by line nurse in white lumen with positive blood return two hours after being placed.When taking tpa of white lumen a weak spot near the hub of the white lumen was noted.The inner layers of the line had become separated and blood was noted between the layers.The line was repair with no harm to the patient.

• Brand Name: HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6578768
• MDR Text Key: 75782453
• Report Number: 3006260740-2017-00659
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869(17)210528(10)HUAS1655
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/19/2017

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: 05/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 0600570
• Device Lot Number: HUAS1655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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