MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABE PORT, CHRONOFLEX, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7380000
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one guidewire within guidewire hoop was received for evaluation.Gross visual, microscopic visual, functional and dimensional testing were performed on the retuned device.The investigation is confirmed for the identified deformation issue as a bent was noted on the distal tip of the guidewire.The investigation is also confirmed for the identified fracture and material protrusion/extrusion issue as the flat inner core wire was observed to be fractured and protruding out of the outer coil of guidewire just proximal to the distal tip.The measurements of the outer diameter of the guidewire recorded during sample evaluation were slightly below specification but not considered definitely out of tolerance as manufactured, as the procedure/use factors could have contributed to a tiny decrease in outer diameter of the guidewire.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 07/2022).
Event or Problem Description
It was reported that during a port implant procedure, the guidewire allegedly had a problem.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS CT LOW-PROFILE POWER-INJECTABLE IMPLANTABE PORT, CHRONOFLEX, 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12958981
• Report Number: 3006260740-2021-05177
• Device Sequence Number: 5449781
• Product Code: LJT
• UDI-Device Identifier: 00801741027451
• UDI-Public: (01)00801741027451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: 7380000
• Device Catalogue Number: 7380000
• Device Lot Number: REEW4904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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
• Patient Sex: Unknown