MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7726950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.The device has yet to be returned for evaluation.
Event or Problem Description
It was reported by the facility, via medwatch, that the patient notified the rn that the white lumen of the catheter was leaking.They stated there was a visible hole in the lumen, chemo blincyto infusing rate 10 ml/hour.No harm to the patient was reported and a catheter repair was successfully done.
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 from the catheter was confirmed, and the damage was determined to be use related.One white connector from what appeared to be the implicated groshong d/l catheter was returned for investigation.The sample revealed evidence of use.A sticky residue was observed on the wings of the white connector.A non-bas injection cap was returned with the white connector.A 2.0cm section of tubing with a white stripe had been advanced 1.15cm over the distal stem of the connector.The clear locking sleeve was not attached to the connector.A breach in the circumferential direction that coincided with the distal tip of the white connector was observed in the tubing.The breach allowed fluid to leak from the catheter.Without the clear locking sleeve, which acts as a strain relief, attached over the catheter and connector, there would be less support at the connection.Flexing the tubing against the distal tip of the connector could eventually cause the material to split open, which would allow fluid to leak.The damage appeared to be associated with use of the device.The product ifu states, ¿secure connector(s) to catheter per the following instructions: cut catheter at a 90° angle and trim external segment of catheter to desired length.For multi-lumen catheters, match the connector hub color to the color of the respective tubing stripes.Transfer clear connector locking sleeve from connector onto catheter.Firmly push catheter onto connector.Slide clear connector locking sleeve over catheter.¿.
Event or Problem Description
It was reported by the facility, via medwatch, that the patient notified the rn that the white lumen of the catheter was leaking.They stated there was a visible hole in the lumen, chemo blincyto infusing rate 10 ml/hour.No harm to the patient was reported and a catheter repair was successfully done.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED
• 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: 6866734
• Report Number: 3006260740-2017-01623
• Device Sequence Number: 18991922
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2017
• Report Date (Section F): 08/09/2017

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 Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REBQ1592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 11/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 08/09/2017