MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK 9.6FR S/L CATH W/VITA; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	0600564
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.One device was returned to bd for the reported malfunction.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 (1) malfunction.A review of the reported malfunction indicated that model 0600564 catheter, intravascular, therapeutic, long-term greater than 30 days allegedly experienced a fluid leak.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a (b)(6) year old female.Weight was not provided for the reported patient.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.One device was returned to bd for the reported malfunction and a leak was identified.The definitive root cause is unknown.The device is labeled for single use.H10: g4 h11: d3, 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 (1) malfunction.A review of the reported malfunction indicated that model 0600564 catheter, intravascular, therapeutic, long-term greater than 30 days allegedly experienced a fluid leak.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a 48 year old female.Weight was not provided for the reported patient.
Event or Problem Description
This report summarizes one malfunction.A review of the reported malfunction indicated that model 0600564 catheter, intravascular, therapeutic, long-term greater than 30 days allegedly experienced a fluid leak.This report was received from one source.This malfunction involved a patient with no patient consequences.The patient was a 48 year old female.Weight was not provided for the reported patient.
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The device was returned for evaluation.The investigation confirmed for fracture and leak.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.

• Brand Name: HICK 9.6FR S/L CATH W/VITA
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; lot #1, road #3, km 79.7; salt lake city UT 84116
• MDR Report Key: 9586486
• Report Number: 3006260740-2020-00053
• Device Sequence Number: 11681036
• Product Code: LJS
• UDI-Device Identifier: 00801741051852
• UDI-Public: (01)00801741051852
• 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,Followup
• Report Date (Section B): 07/13/2020

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: 0600564
• Device Catalogue Number: 0600564
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 03/24/2020; 06/29/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/01/2020; 07/13/2020
• Patient Sequence Number: 1