MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP PLASTIC SINGLE LUMEN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607510
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently under way.Expiration date: 04/2021.
Event or Problem Description
It was reported that the end tip of the port was allegedly identified broken.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged break as no objective evidence has been provided to confirm any alleged deficiency with the port.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include use of hemostats when placing the cathlock on stem and stem crack; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause.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.(expiry date: 04/2021).
Event or Problem Description
It was reported that the end tip of the port was allegedly identified broken.There was no reported patient injury.

• Brand Name: X-PORT ISP PLASTIC SINGLE LUMEN PORT
• 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: 8269423
• Report Number: 3006260740-2018-03900
• Device Sequence Number: 16568415
• Product Code: LJT
• UDI-Device Identifier: 00801741026157
• UDI-Public: (01)00801741026157
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 0607510
• Device Catalogue Number: 0607510
• Device Lot Number: REBX2423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1