MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROV 6.6FR S/L-SHT S; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0600120
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
The lot number was provided and a device history records review was performed.The sample and photos were returned for evaluation.The company is still investigation the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600120 chronic catheter allegedly experienced a crack in the catheter.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.
Additional Manufacturer Narrative
H10: the lot number was provided and a device history records review was performed.The sample and photos were returned for evaluation.The investigation is confirmed for catheter crack and leak issue.A root cause has not been determined.The device was 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600120 chronic catheter allegedly experienced a crack in the catheter.This information was received from one source.The alleged malfunction had patient involvement but there were no reported patient consequences.The age, weight and gender of the patient was not provided.

• Brand Name: BROV 6.6FR S/L-SHT S
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10291575
• Report Number: 3006260740-2020-02565
• Device Sequence Number: 16350134
• Product Code: LJS
• UDI-Device Identifier: 00801741051715
• UDI-Public: (01)00801741051715
• 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): 10/15/2020

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: 0600120
• Device Catalogue Number: 0600120
• Device Lot Number: HUBY0706
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1