MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regn2166 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the "catheter stopped working in the middle of the surgery at the end of the case while removing it the team noticed that part of it is missing done x ray and found the piece of remaining catheter retained in the heart the product removed and send to pathology with a new catheter to compare the 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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter is confirmed; however, the exact cause is unknown.One segment of a dialysis catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The segment was found to be approximately 4 cm long and contained the distal tip.The break site at the proximal end of the catheter segment was observed to be pinched or puckered.A microscopic observation revealed the catheter material at the proximal end of the catheter segment was deformed with the lumens occluded due to this deformation.The outer edges of break site were observed to be mostly smooth and rounded, and the center of the break was observed to be rough with some thinning of the material at the edges.These thinner edges appeared to have been pulled inward towards the center of the catheter, suggesting the catheter may have been pinched repeatedly or for an extended period of time and/or exposed to a high temperature.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer that the "catheter stopped working in the middle of the surgery at the end of the case while removing it the team noticed that part of it is missing done x ray and found the piece of remaining catheter retained in the heart the product removed and send to pathology with a new catheter to compare the device.".

• Brand Name: DUOGLIDE SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15540817
• Report Number: 3006260740-2022-03876
• Device Sequence Number: 1869990
• Product Code: MPB
• UDI-Device Identifier: 00801741042096
• UDI-Public: (01)00801741042096
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5625150
• Device Lot Number: REGN2166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown