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	09/14/2017
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 reap1306 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the doctor couldn't insert the groshong, as the tip "fell off".Another device was used to complete the procedure.No patient injury reported.
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 complainant event was confirmed and the cause was determined to be use related.One 8fr s/l groshong catheter was returned for investigation.The stylet had been removed from the catheter and the tubing was received in two segments.The catheter had been cut between the 19 and 20 cm depth marks.The cuff was not attached to the catheter and was not returned for investigation.What appeared to be blood residue was visible within the distal end of the catheter.A microscopic examination of the catheter revealed adhesive attached to the catheter at the 24cm depth mark.The cuff weave pattern was visible in the adhesive that remained on the catheter.A tactual investigation revealed elastic weakness in the 8 fr tubing between the 24 and 27 cm depth marks, which indicates that the catheter was stretched in the area of the cuff.The ifu indicates to not use the catheter if there is any evidence of mechanical damage.The condition of the returned sample indicates that the product was used.The ifu cautions that the catheter must not be forced during tunneling.The ifu states, ¿gently holding the catheter distal to the cuff while pulling the tunneler and catheter through subcutaneous tunnel should result in smooth passage of the cuff(s) through the subcutaneous tunnel.¿ a lot history review (lhr) of reap1306 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that the doctor couldn't insert the groshong, as the tip "fell off".Another device was used to complete the procedure.No patient injury reported.

• 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: 6993493
• Report Number: 3006260740-2017-01929
• Device Sequence Number: 13776119
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: N/A
• Device Catalogue Number: 7711800
• Device Lot Number: REAP1306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1