MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7726950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebs0439 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the patient was seen in the hospital, while at the facility the patients port was flushed with saline and a crack was noted near the cuff and filled up with saline at the tunnel site.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 9.5 fr dual lumen groshong chronic catheter was returned for evaluation.An initial visual observation showed use residue on the sample and suturing material on the suture wing.The catheter appeared to be trimmed between the 8 cm and 9 cm depth markers.A ¿c¿-shaped split was observed proximal to the tissue ingrowth cuff, between the 24 cm and 25 cm depth markers.Some tensile weakness was observed at the split site during tactile evaluation.Both lumens of the catheter were flushed with a 12 ml syringe of water and a leak was observed in the red (distal) lumen.A microscopic observation revealed the ¿c¿-shaped split had well-defined edges and the fracture surface was observed to be smooth and granular in texture.The shape, location, and texture of the split observed in the returned sample are evidence of a burst failure caused by over-pressurization.A lot history review (lhr) of rebs0439 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the sales rep that the patient was seen in the hospital, while at the facility the patients port was flushed with saline and a crack was noted near the cuff and filled up with saline at the tunnel site.No reported patient injury.

• Brand Name: GROSHONG 9.5 FR DUAL-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: 7043295
• Report Number: 3006260740-2017-02079
• Device Sequence Number: 19122409
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: REBS0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1