MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECU; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7711804
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
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 rebp0596 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the physician that they had difficulty placing the device.It was noted that the tip of the catheter was bent and a "clogged" piece came off during placement.The catheter was not used.A new 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 complaint of a bend in the catheter was confirmed, but the exact cause was unknown.One 8fr s/l groshong catheter was returned for investigation.The catheter was received with the stylet in the lumen.The proximal end of the catheter was positioned 1.5mm from the distal end of the white stylet connector.It appears that the stylet had been repositioned within the catheter.The length of the stylet was within specification.A slight bend was observed in the catheter near the distal end.The catheter may have bent during use since the stylet does not extend into the valved section of tubing.If the catheter was bent during insertion, the bend would have made insertion difficult.Due to the evidence of use and cuff detachment, it appeared than an attempt was made to use the device, but the cause of the reported bend in the catheter was unknown.Sharp or acute angles should be avoided during placement.A lot history review (lhr) of rebp0596 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the physician that they had difficulty placing the device.It was noted that the tip of the catheter was bent and a "clogged" piece came off during placement.The catheter was not used.A new device was used to complete the procedure.No patient injury reported.

• Brand Name: GROSHONG 8 FR SINGLE-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECU
• 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: 7043068
• Report Number: 3006260740-2017-02084
• Device Sequence Number: 1690816
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/02/2018

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: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: REBP0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1