MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS CT LP PRTP 6F; IMPLANTABLE PORT

Model Number	7360001
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported information, the devices were not returned to bd for evaluation.However, one malfunction provided a photo for review.The company is still investigating the issue at this time.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 7360001 implantable port allegedly experienced material frayed.This information was received from various sources.The malfunctions did not involve a patient.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 7360001 implantable port allegedly experienced material frayed.This information was received from various sources.The malfunctions did not involve a patient.Patient age, gender, and weight were not provided.
Additional Manufacturer Narrative
H10: a lot history review was performed as a lot number was provided.For the reported information, the devices were not returned to bd for evaluation.However, one malfunction provided a photo for review.Both investigations were inconclusive for material frayed as no sample was returned for evaluation and the photo provided did not confirm material frayed.Based on the information provided, the definitive root cause is unknown.The devices are labeled for single use.H10: g4 h11: b5, h6(results, conclusion) 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 LP PRTP 6F
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211266
• Report Number: 3006260740-2019-03205
• Device Sequence Number: 305304
• Product Code: LJT
• UDI-Device Identifier: 00801741027444
• UDI-Public: (01)00801741027444
• 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): 01/08/2020

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: 7360001
• Device Catalogue Number: 7360001
• Device Lot Number: REDP2249
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/08/2020
• Patient Sequence Number: 1