MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 VACCESS CT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7360001
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2022).
Event or Problem Description
It was reported that during a port placement, the wire allegedly unraveled while insertion.Therefore, the needle and wire was pulled out as one unit.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one guidewire partially loaded in a guidewire hoop was returned for evaluation.Gross visual, microscopic and dimensional evaluations were performed.The investigation is confirmed for the reported stretched issue and the identified deformation due to compressive stress and fracture issues, as the distal end of the outer coil of the guidewire was observed to be uncoiled just distal to the distal end of the guidewire hoop and bent was noted to guidewire proximal to the guidewire hoop.A brittle like fracture was noted on the distal end of the flat inner core wire.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The dimensions are slightly out of tolerance in the affected portion that may be due to unravelling noted at multiple places in the wire.The dimensions are not out of tolerance for the unaffected portion of the wire.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.H10: d4 (expiry date: 05/2022), h11: h6 (method, result and conclusion), 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.H3 other text : see h10.
Event or Problem Description
It was reported that during a port placement, the wire allegedly unraveled while insertion.Therefore, the needle and wire was pulled out as one unit.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: VACCESS CT POWER PORT
• 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
• MDR Report Key: 11320355
• Report Number: 3006260740-2021-00328
• Device Sequence Number: 10941599
• Product Code: LJT
• UDI-Device Identifier: 00801741027444
• UDI-Public: (01)00801741027444
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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: 7360001
• Device Catalogue Number: 7360001
• Device Lot Number: REEW1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR
• Patient Weight: 52