MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 3F SL MAX 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional 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 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.
Event or Problem Description
It was reported by the customer that in some of the kits recently, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the midline containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.A specific number of affected devices or patients was no provided by the complainant.
Additional 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 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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that in some of the kits recently, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the midline containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.It was reported this occurred with seven devices.This report addresses the first device.
Additional 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.An investigation was conducted based on the known detail surrounding the event, the returned sample, and the provided product information.The complaint of leak in the hub was confirmed.The sample was evaluated and this event was determined to be related to a manufacture condition.Bd is working to prevent future occurrences of similar events.
Event or Problem Description
It was reported by the customer that in some of the kits recently, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the midline containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.It was reported this occurred with seven devices.This report addresses the first device.

• Brand Name: DOT PROV 3F SL MAX 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17712239
• Report Number: 3006260740-2023-04004
• Device Sequence Number: 3453133
• Product Code: LJS
• UDI-Device Identifier: 00801741130342
• UDI-Public: (01)00801741130342
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S1173108D
• Device Lot Number: REHQ3537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/17/2023; 10/12/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/29/2023; 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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