MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (ALPHACURVE) (19CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5835150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
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 rebx2105 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a dislodgement of the hemostar alpha curve.Allegedly the catheter slipped out after one month of insertion.There was 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 catheter dislodgement was inconclusive with the provided sample.The product returned for evaluation was a 19cm hemostar catheter.The sample contained extensive red usage residue throughout the catheter and cuff.Gross visual evaluation of the cuff was unremarkable.The cuff was found to be securely attached to the catheter at the intended location marker.Microscopic examination was likewise unremarkable.The cuff was measured to be within specification.No potential manufacture cause to loose tissue ingrowth was observed during the sample evaluation.As a note, the intent of the cuff is to help secure the catheter and aid in reducing bacteria from entering the body.The catheter must be otherwise secured as the cuff does not provided full catheter securement.A lot history review (lhr) of rebx2105 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that there was a dislodgement of the hemostar alpha curve.Allegedly the catheter slipped out after one week or one month of insertion.Customer is questioning about the tissue ingrowth cuff and wants us to investigate the cause of slippage of catheter.If there is any tissue ingrowth, how come the catheter can slip out after one month of insertion?.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (ALPHACURVE) (19CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7304218
• Report Number: 3006260740-2018-00311
• Device Sequence Number: 16479413
• Product Code: MSD
• UDI-Device Identifier: 00801741013485
• UDI-Public: (01)00801741013485
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: 5835150
• Device Catalogue Number: 5835150
• Device Lot Number: REBX2105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1