MAUDE Adverse Event Report: BARD ACCESS SYSTEMS KIT TO CHRFX ATT 8FR PEE; IMPLANTABLE PORTS

Model Number 0605320

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0605320 implantable port allegedly experienced detachment of device and leak.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old female is (b)(6) kgs.

Manufacturer Narrative

H10: the lot number was provided; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0605320 implantable port allegedly experienced detachment of device and leak.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 15 year old female is 75 kgs.

• Brand Name: KIT TO CHRFX ATT 8FR PEE
• Type of Device: IMPLANTABLE PORTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10286360
• MDR Text Key: 199478589
• Report Number: 3006260740-2020-02488
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025907
• UDI-Public: (01)00801741025907
• 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: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0605320
• Device Catalogue Number: 0605320
• Device Lot Number: RECQ0494
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1