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

Model Number	7496000
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10743256
• Report Number: 3006260740-2020-03506
• Device Sequence Number: 3486309
• Product Code: LJT
• UDI-Device Identifier: 00801741027482
• UDI-Public: (01)00801741027482
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 7496000
• Device Catalogue Number: 7496000
• Device Lot Number: REDY3078
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1