MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reav2473 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the groshong line was placed but appeared to be damaged on the final check.The catheter was removed and a second line placed.After removal, it was stated that fluid could be seen leaking from under the cuff.
Additional 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 leak in the catheter was confirmed, and the damage appeared to be associated with use of the device.One 8fr groshong catheter was returned for investigation.The connector was attached to the tubing, which indicates that the catheter had been placed.It was reported that the catheter appeared damaged after placement.A functional test of the catheter revealed fluid leaking from the catheter at the proximal end of the catheter.A microscopic examination revealed circumferential tears in the catheter between the proximal end of the cuff and the 25 cm depth mark.The proximal end of the cuff was separating from the underlying adhesive.Elastic weakness was detected in the 3.5cm section of tubing just proximal to the cuff.Circumferential splits were also observed at the 25 ¿ 27 cm depth marks, which were located in the weakened section of tubing.The weakness in the tubing indicates that the tubing was stretched during placement, which may have been a contributing factor in the catheter damage.The cuff may have been difficult to tunnel.When tunneling, the product ifu states, ¿the catheter must not be forced.¿.
Event or Problem Description
It was reported that the groshong line was placed but appeared to be damaged on the final check.The catheter was removed and a second line placed.After removal, it was stated that fluid could be seen leaking from under the cuff.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6800213
• Report Number: 3006260740-2017-01310
• Device Sequence Number: 11193250
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 7711800
• Device Lot Number: REAV2473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1