MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA AND PROBE COVER; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.Device not returned for evaluation.
Event or Problem Description
It was reported via ms&s: caller states she is working with a patient that has powerpicc s4153108dgp (lot number regy0370) and can flush into the picc easily but cannot get a blood return.Caller asking if we can provide cathflo to help with the occlusion and how to administer cathflo.Ms&s response: explained that a fibrin tail can form near the top of the catheter.When the picc is flushed with saline the fibrin tail is not an issue.When aspirated for a blood return the fibrin tail can be drawn into the catheter tip occluding the lumen.Confirmed the cathflo can be used to help alleviate occlusions caused by fibrin tails.Explained she would need to follow the instructions for cathflo usage.Explained that bd does not provide cathflo to customers.Suggested she call the doctor and discuss further.

• Brand Name: 3FR SL PROVENA MIDLINE MAX BARRIER KIT W/GUARDIVA AND PROBE COVER
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16632675
• Report Number: 3006260740-2023-01045
• Device Sequence Number: 17934679
• Product Code: PND
• UDI-Device Identifier: 00801741154027
• UDI-Public: (01)00801741154027
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S4153108DGP
• Device Lot Number: REGY0370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown