MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (TRIPLE-LU; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redv2039 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that the catheter twists or expands before introduction.No other information was provided.It was reported this occurred with two devices.This addresses the second device.
Event or Problem Description
It was reported that the catheter twists or expands before introduction.No other information was provided.It was reported this occurred with two devices.This addresses the second device.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of damage dilator tips is confirmed but the exact cause remains unknown.One photo sample of two dilators were provided for evaluation.The dilators shown appear to be different sizes.The distal sections of the dilators are shown without the proximal hubs being visible.Blood residue is present on the dilator shafts.The distal tips appear deformed with light material discoloration being present.The dilator on the bottom side shows more deformation with the distal tip being round outwards.The dilator on the top side appears to be compressed or bent near the distal shaft end.Based on the evidence of use and deformation visible, possible contributing factors include advancement against resistance and insertion technique.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the dilators were observed to be damaged, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of redv2039 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in france.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (TRIPLE-LU
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10512110
• Report Number: 3006260740-2020-03198
• Device Sequence Number: 19471450
• Product Code: NIE
• UDI-Device Identifier: 00801741042003
• UDI-Public: (01)00801741042003
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5618240
• Device Lot Number: REDV2039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1