MAUDE Adverse Event Report: BARD ACCESS SYSTEMS L/P TI CHRFX ATT 6FR DAI; IMPLANTABLE PORT

Model Number	0605550
Medical Device Problem Code	Material Frayed (1262)
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 indicated that model 0605550.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no patient consequences.The patient is (b)(6) years of age, the gender is female, and the weight is (b)(6) kgs.
Additional Manufacturer Narrative
H10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is confirmed for guidewire breakage/unraveling.A root cause has not been determined.The device is labeled for single use.H10: g4 h11: 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0605550.Implantable port allegedly experienced material frayed.This report was received from a single source.This event did involve patient with no patient consequences.The patient is 5 years of age, the gender is female, and the weight is 16 kgs.

• Brand Name: L/P TI CHRFX ATT 6FR DAI
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9598349
• Report Number: 3006260740-2020-00159
• Device Sequence Number: 2473786
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• 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): 04/03/2020

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: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: REDN2434
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1