MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	7726950
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the catheter broke during the insertion process.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Device history records were reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.Manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the manufacturing process.One groshong 9.5f d/l catheter in two segments was returned for evaluation.Visual, microscopic, and dimensional evaluations were performed.The investigation is confirmed for a catheter break, as the red and white extension legs were found broken off from the bifurcation hub.The two ends of both the red and white legs were found to be finely granular, with evidences of cloudiness/clear material at the ends and a definite ring near the tip of the red lumen, consistent with adhesive or similar.The definitive root cause could not be determined based upon available information.However, the report that the catheter broke during insertion and the location of the break and the break surfaces of the two extension legs are consistent with a break due to pulling forces during tunneling.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiration date: 01/2023).
Event or Problem Description
It was reported that the catheter broke during the insertion process.Another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7741387
• Report Number: 3006260740-2018-01905
• Device Sequence Number: 1049808
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: RECN0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1