MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 8F POLYURETHANE OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1608052

Device Problems Component Missing (2306); Incomplete or Missing Packaging (2312)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

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 Description

It was reported that the port kit contained an 18 g needle, but the description on the package says 21 g needle.The needle discrepancy was discovered during the procedure.A different needle was used to complete the procedure.There was no reported patient injury.

Event Description

It was reported that the port kit contained an 18 g needle, but the description on the package says 21 g needle.The needle discrepancy was discovered during the procedure.A different needle was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

The device history records have been reviewed and this lot met all release criteria.There was nothing found in the review to indicate there was a manufacturing related cause for this event.Eight sealed powerport clearvue isp w 8 fr s/l polyurethane catheter kit lot samples were returned for evaluation and three photos of the original sample were provided for review.The eight returned devices were visually inspected and confirmed to have the incorrect size needle based on the color of the hub in each kit compared to the contents list on each label.Photos of the evaluation were reviewed by the manufacturing site, bard reynosa, and the incorrect size needle was confirmed to be a manufacturing-related issue.Additionally, the device pictured in the photos was confirmed to have the same issue based on the color of the hub not matching the contents list on the label.Based on these findings, the investigation is confirmed for the reported incorrect needle size for a quantity of nine port kits.Per bard reynosa's evaluation, the root cause for the reported event is manufacturing-related.Labeling review: reynosa evaluation baw0737454 rev.0 ifu, powerport precautions i.Prior to placement: examine package carefully before opening to confirm its integrity and that the expiration date has not passed.The device is supplied in a double sterile package and is non-pyrogenic.Do not use if package is damaged, opened or the expiration date has passed.Sterilized by ethylene oxide.Do not resterilize.Inspect kit for presence of all components.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• Brand Name: POWERPORT CLEARVUE IMPLANTABLE PORT WITH ATTACHABLE 8F POLYURETHANE OPEN-ENDED
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7580634
• MDR Text Key: 110452614
• Report Number: 3006260740-2018-01291
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026423
• UDI-Public: (01)00801741026423
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 1608052
• Device Catalogue Number: 1608052
• Device Lot Number: RECR0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1