MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reen4744 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the curved extension legs are pulling on the insertion site and causing the dressings to lift off of the skin.

Event Description

It was reported that the curved extension legs are pulling on the insertion site and causing the dressings to lift off of the skin.

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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of the dialysis catheter extension tubes pulling on the insertion site and lifting the dressing was inconclusive.The product returned for evaluation was one photograph which depicted a pre-curved dialysis catheter.The depicted device was implanted and extension tubes were attached to both luer adapters.The pre-curved extension legs were visible protruding from the dressing at the patient¿s neck.The top left corner of the dressing appeared lifted away from the skin.The depicted device appeared unremarkable, but it could not be thoroughly examined.While the corner of the dressing appeared to be lifted away from the skin, this could neither be confirmed or attributed to device form or function.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10759342
• MDR Text Key: 215269358
• Report Number: 3006260740-2020-20292
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741042058
• UDI-Public: (01)00801741042058
• Combination Product (y/n): N
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5624120
• Device Lot Number: REEN4744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 11/30/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other