MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BROV 6.6FR S/L W/VITA & 7FR PIK; CHRONIC CATHETER

Model Number	0600544
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device has been 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 0600544 chronic catheter allegedly experienced material puncture/hole.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The (b)(6) year old female patient was (b)(6) kg.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600544 chronic catheter allegedly experienced material puncture/hole.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 6 year old female patient was 21 kg.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.The investigation is currently underway.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.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation.The investigation of the returned device was confirmed for split on the lumen.Based on the available information, a definitive root cause of the event 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 or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600544 chronic catheter allegedly experienced material puncture/hole.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The 6 year old female patient was 21 kg.

• Brand Name: BROV 6.6FR S/L W/VITA & 7FR PIK
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9965321
• Report Number: 3006260740-2020-01325
• Device Sequence Number: 16858332
• Product Code: LJS
• UDI-Device Identifier: 00801741051838
• UDI-Public: (01)00801741051838
• 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): 10/12/2020

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: 0600544
• Device Catalogue Number: 0600544
• Device Lot Number: HUBT1757
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 09/30/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 07/02/2020; 10/12/2020
• Patient Sequence Number: 1