MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT DUO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK POWER PORT DUO

Device Problem Fracture (1260)

Patient Problems Neck Pain (2433); Swelling/ Edema (4577)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that post port device implant, the catheter was allegedly broken and was causing swelling and neck pain when tried to infuse the device.The device was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the sample was not returned for evaluation, however, a medical record review was performed.The investigation is confirmed for the reported catheter fracture.According to the medical record, approximately two years and six months post port deployment, the patient presented with pain and swelling at the port when the port was injected.On the same day, an attempt was made to retrieve the tunneled port from the patient¿s body.The existing port was accessed.Subsequently venogram was performed.Incision was made through the right chest subcutaneous tissues.The port was freed from the surrounding tissues.The catheter was removed over a wire.The device was replaced.Visual inspection of the catheter showed a break in the catheter, at the location of the neck.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.H11: section a through f: the information provide by bd represents all 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.H3 other text : device not returned.

Event Description

It was reported through the litigation process that post port device implant, the catheter was allegedly broken and was causing swelling and neck pain when they tried to infuse the device.The device was removed.The current status of the patient is unknown.

• Brand Name: POWER PORT DUO
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11671985
• MDR Text Key: 245595098
• Report Number: 3006260740-2021-01338
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK POWER PORT DUO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR