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

Model Number N/A

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported ¿many cvc fasteners have been becoming disconnected from the catheters.This poses a safety risk in from both an infection prevention and possible dislodgement of the cvc catheter.[a physician] who was in the meeting stated those fasteners do not work well.They do not completely grasp the lumens and therefore, easily dislodges.We have heard from our staff that this has been happening for the past month or so.¿.

Event Description

It was reported ¿many cvc fasteners have been becoming disconnected from the catheters.This poses a safety risk in from both an infection prevention and possible dislodgement of the cvc catheter.[a physician] who was in the meeting stated those fasteners do not work well.They do not completely grasp the lumens and therefore, easily dislodges.We have heard from our staff that this has been happening for the past month or so.¿.

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, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached suture wing is confirmed; however, the exact cause is unknown.One photograph of a dressed dialysis catheter was returned for evaluation.An initial visual observation of the photograph showed a guardiva device, an attachable suture wing, and an inserted catheter underneath a clear dressing.The guardiva device and the attachable suture wing were observed to not be attached to the catheter.Suture material could be seen on the wings of the attachable suture wing, but no suturing material could be seen on the suture grooves of the attachable suture wing.While the exact cause of the detached suture wing could not be determined from the returned photograph, possible causes include improper securement of the attachable suture wing, material fatigue, and sharp instrument damage.As a note, the product ifu states: ¿secure the wing onto the catheter by tying sutures around the wing using the suture grooves.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER
• 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: 10686466
• MDR Text Key: 213479740
• Report Number: 3006260740-2020-20135
• Device Sequence Number: 1
• Product Code: MPB
• 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: 01/25/2021

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: 5624150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/15/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other