MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 0600600

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.

Event Description

It was reported that the hickman was placed and when the hcp went to flush the device, fluid squirted out.The device was replaced.There was no reported patient injury.

Event Description

It was reported that the hickman was placed and when the hcp went to flush the device, fluid squirted out.The device was replaced.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the returned device was one 9 fr d/l hickman catheter.Visual observation found a pinhole just distal to the white luer hub and just proximal to the point where the stem on the inside terminates; this leaked during infusion of the white lumen against resistance.The cuff appeared very clean.Tactual evaluation found clamp marks in the clamping sleeves of both the red and the white extension legs.Microscopic evaluation found the hole on the outside extended through to the inside, where the edges of the hole appeared rounded and somewhat polished.It terminated just distal to the point where the luer adaptor stem would have sat.The complaint of a leak in the catheter is confirmed.The characteristics found during sample evaluation are consistent with the known issue of clamping too near the connector; however, it is possible that other factors such as tool damage and excessive pulling contributed to this event.The cause of this event is therefore unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 07/2021).

• Brand Name: HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7466454
• MDR Text Key: 106742808
• Report Number: 2020394-2018-00491
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051890
• UDI-Public: (01)00801741051890
• Combination Product (y/n): N
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600600
• Device Catalogue Number: 0600600
• Device Lot Number: HUBQ1740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 102