MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK 7FR D/L CATH; CHRONIC CATHETER

Model Number	0600310
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned for evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600310.Chronic catheter allegedly experienced material perforation.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.
Additional Manufacturer Narrative
The lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device has been returned for evaluation; the evaluation identified circumferential rupture and break along with leak from the split.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.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 0600310 chronic catheter allegedly experienced material perforation.This report was received from a single source.This event did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: HICK 7FR D/L CATH
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9582945
• Report Number: 3006260740-2020-00048
• Device Sequence Number: 16914042
• Product Code: LJS
• UDI-Device Identifier: 00801741051739
• UDI-Public: (01)00801741051739
• 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): 04/02/2020

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: 0600310
• Device Catalogue Number: 0600310
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1