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	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 has been returned 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
During decontamination of the device, there were holes found on the bottom side of the port.There was no reported patient injury.
Event or Problem Description
It was reported that there were alleged holes identified on the bottom side of the port.There was 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.Investigation summary: one m.R.I.Lp plastic port was returned for evaluation and two photos of the port base were provided for review.This investigation will only consider the reported event of holes in the port base, as multiple complaints were reported for this device.In both the photo review and sample evaluation, it was noted that there were holes in the port base and leaking observed at the site of the holes.The evaluation results also noted multiple scratches on the port body.Based on these findings, the investigation is confirmed for the reported holes in the port base.Based on the evaluation results, the two holes in the port base were consistent with puncture marks from a sharp instrument and multiple access punctures were seen in the port septum.Therefore, it is possible that damage from a needle contributed to the reported event.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Possible contributing factors include inappropriate needle length selection and inability to accurately determine port depth.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• 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: 7830845
• Report Number: 3006260740-2018-02262
• Device Sequence Number: 11346884
• 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): 01/28/2019

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: 08/06/2018
• Supplement Date Received by Manufacturer: 01/12/2019
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1