MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARDPORT TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0606150

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

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 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.Device not returned at this time.

Event Description

It was reported that the dressing was discovered to be wet.X-ray found that the catheter was position in the jugular vein instead of the subclavian vein.Repositioning of the catheter was not successful.The device was removed and a new port is schedule to be placed.No patient injury reported.

Event Description

It was reported that the dressing was discovered to be wet.X-ray found that the catheter was position in the jugular vein instead of the subclavian vein.Repositioning of the catheter was not successful.The device was removed and a new port is schedule to be placed.No patient injury reported.

Manufacturer Narrative

After further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is 3006260740.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The 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 that has been reported for this corporate lot number to date.Investigation summary: the device was returned and evaluated.A visual and tactile evaluation was performed.Evidence of use was noted throughout, as multiple punctures were noted on the port septum.A catheter kink was also noted; however, the original report did not alleged any kinks and it is unknown if port removal and/or handling conditions contributed to the return condition.Therefore, the observed kink will be conditioned incidental.The investigation is inconclusive for catheter malposition as the return sample could not confirm the alleged deficiency and no images were provided for review.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the reported event.

• Brand Name: BARDPORT TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7488583
• MDR Text Key: 107458112
• Report Number: 2020394-2018-00567
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0606150
• Device Catalogue Number: 0606150
• Device Lot Number: REBV0384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 110