MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 3FR PROVENA MIDLINE MAX BARRIER KIT; MIDLINE CATHETER

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

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.The device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.

Event Description

It was reported by customer that powermidline is leaking at the t connector.They have to manipulate to get it to work correctly.Had to spend extra time working around the problem.No other information was provided.

Manufacturer Narrative

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.The complaint of a leak through the t-lock septum was confirmed.A single photograph of the implanted 3fr s/l midline provena catheter was returned for evaluation.The t-lock assembly was still attached to the catheter luer adaptor and the stylet was inlaid.A drop of red fluid was seen on the outer surface of the t-lock septum.In addition, the extension leg tubing of the t-lock assembly appeared to contain both red fluid and air which may indicate air leakage into the device during aspiration.The characteristics seen on the returned photograph indicate a potential leak at the septum.The leak was likely located where the stylet traversed through the t-lock septum and may have occurred as a result of the manufacturing process.Bd is working closely with the supplier/manufacturing to prevent recurrence of the reported event.H3 other text: evaluation findings are in section h11.

Event Description

It was reported by customer that powermidline is leaking at the t connector.They have to manipulate to get it to work correctly.Had to spend extra time working around the problem.No other information was provided.

• Brand Name: 3FR PROVENA MIDLINE MAX BARRIER KIT
• Type of Device: 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17321745
• MDR Text Key: 319034159
• Report Number: 3006260740-2023-02965
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741153952
• UDI-Public: (01)00801741153952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S4153108D
• Device Lot Number: REGZ2083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other