MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARDPORT M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH PRE-ATTACHED 6.6F OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	6603880
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the port became disconnected with perforations at the base causing leakage.The device was reportedly removed.There is no reported patient injury.
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one m.R.I.Lp plastic port with 6.6 fr s/l silicone catheter and six electronic photos were returned for evaluation.Functional, gross visual, microscopic visual, tactile and dimensional evaluations were performed.The investigation is confirmed for a catheter break at the port stem, as a fragment of interim tubing was observed on the port stem.The break surface of the fragment located on the port stem has roughness and an uneven break surface consistent with tearing.The cath-lock had scratches and chips on the surface which are consistent with characteristics of manipulation of the cath-lock with tools/instruments.The inner and outer diameters of the catheter tubing were measured and found to be within specifications.From the diameters measured in the catheter tubing the wall thickness was computed to 0.0224 in., which is within specifications.The diameter of the widest region of the port stem barb was found to be within specifications.The narrowest constriction of the cath-lock was measured to be 0.0947 in.And specifications are 0.092 in.To 0.094 in.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.
Event or Problem Description
It was reported that the port became disconnected with perforations at the base causing leakage.The device was reportedly removed.There is no reported patient injury.

• Brand Name: BARDPORT M.R.I. LOW-PROFILE IMPLANTABLE PORT WITH PRE-ATTACHED 6.6F OPEN-ENDED
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7648524
• Report Number: 3006260740-2018-01528
• Device Sequence Number: 1651722
• Product Code: LJT
• UDI-Device Identifier: 00801741027413
• UDI-Public: (01)00801741027413
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 6603880
• Device Catalogue Number: 6603880
• Device Lot Number: REXJ1070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1