MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 6F RADIOLOGY BASIC TRAY TL (135CM NITINOL GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported device presents damage to its catheter segment at 40 cm.The device was not used in the patient, the event occurred in the installation process, for which another catheter of the same reference had to be opened, without problems.Additional information received 02 nov 2022: was the deviation identified when opening the package? the product is verified defective at the moment of opening the packaging visually.Was the catheter infused with saline prior to detection? no, as this was visually verified before use.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reft2033 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported device presents damage to its catheter segment at 40 cm.The device was not used in the patient, the event occurred in the installation process, for which another catheter of the same reference had to be opened, without problems.Additional information received 02.Nov.2022: it was reported by the customer the product damage was visually verified at the moment of opening the package, before use on the patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged catheter was confirmed; however, the exact root cause was not identified.The product returned for evaluation was one 6fr t/l powerpicc catheter.The sample was received in its original packaging.The catheter appeared free of use residues.Catheter damage was observed between the 39cm and 42cm depth markings, including a diagonally aligned split at the 40cm depth marking.Microscopic inspection of the split site revealed a fracture that exhibited severe material flow and discoloration.Coarse striations were observed at the split site and in the vicinity.Abundant superficial splits with discoloration and material flow were observed.The catheter split and nearby superficial scoring marks and material flow were consistent with damage caused by contact between the catheter and a heated metal surface.The lack of apparent use residues suggested that damage may have occurred during device assembly and packaging.Photographs have been forwarded to the manufacturing site for further evaluation.Based on evaluation completed by the manufacturing site, the observed catheter damage may potentially have occurred during device manufacture; however, an exact root cause could not be identified.Consequently this complaint is confirmed as 'cause unknown' at this time.

• Brand Name: POWERPICC 6F RADIOLOGY BASIC TRAY TL (135CM NITINOL GUIDEWIRE)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15756955
• Report Number: 3006260740-2022-04462
• Device Sequence Number: 15012507
• Product Code: LJS
• UDI-Device Identifier: 00801741028304
• UDI-Public: (01)00801741028304
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3386335
• Device Lot Number: REFT2033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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: Other
• Patient Sex: Unknown