MAUDE Adverse Event Report: BARD ACCESS SYSTEMS RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN) (23CM; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
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 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 that the catheter could not be aspirated was unconfirmed as the problem could not be replicated.One 23cm implant length / 28cm body length retro catheter was returned for investigation.The intracatheter stylet was received in the venous (blue) lumen.Blood residue was observed on the catheter, which indicates that the product was used.The extension legs had been trimmed at the 40cm depth mark.The connectors were not attached to the extension legs.A functional test revealed that the catheter lumens were patent to infusion and aspiration.Even though the reported event could not be replicated on the returned device, the problem could be associated with the clinical setting.It was reported that the catheter was primed prior to insertion without any problem.It was after insertion that the problem with aspiration was detected.The difficulty with aspiration could be associated with kinking or tip malposition.No damage or defects were observed on the returned device.A lot history review (lhr) of aszl0002 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that after opening the retro catheter, it was primed without any problem observed.It was stated that the catheter insertion was smooth, but the catheter could not be aspirated right after the procedure.The retro catheter was then removed and a new retro catheter was used for the patient without any problem.

• Brand Name: RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE TRAY (DUAL-LUMEN) (23CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6501499
• Report Number: 3006260740-2017-00429
• Device Sequence Number: 19196920
• Product Code: MSD
• UDI-Device Identifier: 00801741014062
• UDI-Public: (01)00801741014062(17)190528(10)ASZL0002
• Combination Product (Y/N): N
• PMA/510(K) Number: K022000
• 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
• Report Date (Section B): 04/18/2017

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: 05/28/2019
• Device Model Number: N/A
• Device Catalogue Number: RS23SH28
• Device Lot Number: ASZL0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2017
• Initial Report FDA Received Date: 04/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1