MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, SILICONE, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7496000

Device Problems Fracture (1260); Material Separation (1562); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 7496000 port & catheter, implanted, subcutaneous, intravascular allegedly experienced fracture.The information was received from a single source.This malfunction involved one patient with no patient consequences.A (b)(6) years old female patient weighs (b)(6) lbs.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 7496000 port & catheter, implanted, subcutaneous, intravascular allegedly experienced fracture.The information was received from a single source.This malfunction involved one patient with no patient consequences.A 55 years old female patient weighs 275 lbs.

Manufacturer Narrative

H10: the lot number for the device was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigating is confirmed for material separation, detachment and separation failure; however, the investigation is inconclusive for the reported catheter damage.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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.

• Brand Name: VACCESS CT POWER-INJECTABLE IMPLANTABLE PORT, SILICONE, 9.6F
• 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: 10743256
• MDR Text Key: 213930254
• Report Number: 3006260740-2020-03506
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027482
• UDI-Public: (01)00801741027482
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7496000
• Device Catalogue Number: 7496000
• Device Lot Number: REDY3078
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1