MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7711804
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2017
Type of Reportable Event	Malfunction
Additional 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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebq1663 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the groshong worked okay and then today a leak was noted at the insertion site.The catheter was removed on (b)(6) 2017 and a split was noted near the end of the catheter.No reported patient injury.
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 is confirmed and was determined to be use related.One 8 fr clearvue groshong chronic catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.A split was observed in the catheter approximately 2.9 cm distal to the cuff.The sample was flushed with a 12 ml syringe of water and was found to be patent to infusion and aspiration; however a spraying leak was observed emanating from the split in the catheter.A microscopic observation revealed an additional, smaller split opposite the larger split.Both splits were observed to be irregularly shaped and jagged.The surface of the splits was observed to be mostly granular in texture.Striations were observed in parts of both splits, indicating damage from a ground-sharpened instrument.As a note, the product ifu states: ¿avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth-edged atraumatic clamps or forceps¿ and ¿use suture wings to secure catheters.¿ a lot history review (lhr) of rebq1663 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the groshong worked okay and then today a leak was noted at the insertion site.The catheter was removed on (b)(6) 2017 and a split was noted near the end of the catheter.No reported patient injury.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: 7162730
• Report Number: 3006260740-2017-02357
• Device Sequence Number: 16623826
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2018

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 Model Number: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: REBQ1663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1