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

Model Number 0605550

Device Problem Material Frayed (1262)

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 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.

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 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
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9598349
• MDR Text Key: 182525782
• Report Number: 3006260740-2020-00159
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025976
• UDI-Public: (01)00801741025976
• 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: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0605550
• Device Catalogue Number: 0605550
• Device Lot Number: REDN2434
• Date Manufacturer Received: 03/25/2020
• Patient Sequence Number: 1