MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI HARD B ATT OPEN 9.6; IMPLANTABLE PORT

Model Number	0604550
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that the healthcare provider allegedly found a plastic ring on the dilator component.It was further reported that the plastic ring was removed and the procedure was safely completed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: based upon the severity level and lot quantity, a dhr review is required.The lot met all release criteria.Dhr was reviewed and no deviations/issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards the problem described.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for foreign material present on device, as the photo shows the dilator tip with a what seems to be a clear piece of protective tubing attached.The root cause was determined to be manufacturing related.An operator forgot to remove the tip protective from the dilator.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.
Event or Problem Description
It was reported that the healthcare provider allegedly found a plastic ring on the dilator component.It was further reported that the plastic ring was removed prior to implanted the port device.Reportedly, another peel-away sheath was used in the completion of the procedure.There was no harm to the patient.

• Brand Name: MRI HARD B ATT OPEN 9.6
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189389
• Report Number: 3006260740-2018-03706
• Device Sequence Number: 1961136
• Product Code: LJT
• UDI-Device Identifier: 00801741025860
• UDI-Public: (01)00801741025860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 0604550
• Device Catalogue Number: 0604550
• Device Lot Number: REBR0365
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1