MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SL WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 7617405

Device Problems Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx3682 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that this patient complained of pain after a catheter was placed and an ultrasound indicated thrombus.No other information was provided.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed, but the exact cause could not be determined.One 4fr groshong single-lumen picc was returned for investigation.The catheter was received in two segments.A tactual investigation revealed no significant elastic weakness in the tubing.The distal segment was 41cm in length.The proximal segment of tubing was attached and secured to the two-piece connector.The adjoining ends of the catheter were located between the 40 and 41 cm depth marks.A microscopic examination of the adjoining ends of the catheter revealed that the contours did not match.When the depth marks were positioned against a ruler, it appears that approximately 1mm of tubing was missing.The adjoining ends of the catheter were uneven and granular.A silvery material was observed on the tubing at the adjoining ends of the catheter.A hole was observed in the tubing at the 19cm depth mark.The same silvery material was observed at the 19cm depth mark.Material had been removed from the catheter at the hole and from the external surface of the tubing around the hole.Had the hole existed at the time the catheter was flushed prior to placement, a leak would have been obvious.A functional test revealed no leaks in the catheter, except at the hole, which was located at the 19cm depth mark.The leak in the tubing could be associated with the reported pain; however, the cause of the leak and break in the tubing could not be determined.No damage associated with the manufacturing process was observed on the returned sample.H3 other text: evaluation findings are in section h.11.

Event Description

It was reported that this patient complained of pain after a catheter was placed and an ultrasound indicated thrombus.No other information was provided.

• Brand Name: GROSHONG NXT CLEARVUE 4F SL WITH SAFETY INTRODUCER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11140331
• MDR Text Key: 227089392
• Report Number: 3006260740-2020-21231
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7617405
• Device Catalogue Number: 7617405
• Device Lot Number: RECX3682
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention