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	Chemical Exposure (2570)
Date of Event	08/04/2017
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 for evaluation.A lot history review (lhr) of reaz0623 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reaz0623) have been reported from the same facility.
Event or Problem Description
It was reported by the facility, via medwatch, that this is the second incident that the groshong failed on the same day.It was reported to be irreparable.They stated that the patient was found to be wet in bed, the groshong catheter was "broken" and ivf was leaking on to the bed and floor.The lumen was repaired and alteplase was administered to the white lumen to resolve the clot.
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 break in the catheter was inconclusive due to the sample condition.One white connector from what appeared to be the implicated d/l groshong catheter was returned for investigation.The clear locking sleeve was received separate from the connector.No portion of the catheter tubing was attached to the connector or returned for investigation.Residue was observed on the white connector and the locking sleeve.A non-bas injection cap was returned with the white connector.The connecting features of both the white winged connector and connector locking sleeve were within specification and no damage was observed on the returned components.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
Event or Problem Description
It was reported by the facility, via medwatch, that this is the second incident that the groshong failed on the same day.It was reported to be irreparable.They stated that the patient was found to be wet in bed, the groshong catheter was "broken" and ivf was leaking on to the bed and floor.The lumen was repaired and alteplase was administered to the white lumen to resolve the clot.

• 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: 6866715
• Report Number: 3006260740-2017-01625
• Device Sequence Number: 13794113
• 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 Expiration Date: 11/30/2021
• Device Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REAZ0623
• 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: 08/04/2017
• 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: 78 YR
• Date Report Sent to FDA: 08/09/2017