MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0605640
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a port placement procedure, the guidewire was allegedly stuck in the introducer needle and could not be removed from the introducer needle.The guidewire and the introducer needle were removed together and damage was found on the removed guidewire.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one tunneler, one cath-lock, one vein pick and one guidewire in guidewire hoop were returned for evaluation.Visual, microscopic, tactual, functional, and dimensional evaluations were performed.The investigation can be confirmed for the identified deformation, fracture and stretching issues as the outer coil and flat core wire were both found to be bent and the flat core wire was protruding from the outer coil.However, the investigation is inconclusive for the reported failure to advance and difficult to remove issues as exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.Based upon the available information, the definitive root cause for this event is unknown.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: g3, h6 (device).H11: h6 (result, 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 procedure, the guidewire was allegedly stuck in the introducer needle and could not be removed from the introducer needle.The guidewire and the introducer needle were removed together and damage was found on the removed guidewire.There was no reported patient injury.

• Brand Name: M.R.I. ULTRA SLIMPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F
• 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: 12272800
• Report Number: 3006260740-2021-03097
• Device Sequence Number: 2839795
• Product Code: LJT
• UDI-Device Identifier: 00801741025990
• UDI-Public: (01)00801741025990
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 0605640
• Device Catalogue Number: 0605640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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