MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606100C

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Malposition of Device (2616)

Patient Problem Swelling (2091)

Event Date 06/06/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, the photo and image were provided for review.The investigation of the reported event is currently underway.Expiry date (10/2021).The catalog number identified in section has not been cleared in the us but is similar to the titanium low-profile implantable port, broviac single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the titanium low-profile implantable port, broviac single-lumen, 6.6f products is identified.

Event Description

It was reported that approximately two days post port placement, the patient experienced swelling.It was further reported chest radiography examination showed indwelling tube was in abnormal position.Reportedly the tube was removed.The patient heath status was normal.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however,one medical image and one electronic photo was provided for review.The investigation is confirmed for catheter fracture and catheter migration as the photo and image review shows catheter broken at the port stem, port catheter hub with no tubing attached and there is a catheter tubing overlying the right heart.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, broviac single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the titanium low-profile implantable port, broviac single-lumen, 6.6f products is identified in d2 and g5.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that approximately two days post port placement, the patient experienced swelling.It was further reported chest radiography examination showed indwelling tube was in abnormal position.Reportedly the tube was removed.The patient heath status was normal.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT, BROVIAC SINGLE-LUMEN, 6.6F
• 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: 10336897
• MDR Text Key: 200764895
• Report Number: 3006260740-2020-02692
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111181
• UDI-Public: (01)00801741111181
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0606100C
• Device Lot Number: RECX3505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR