MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL FULL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Bd vascular access devices field assurance received a leaking picc for evaluation.A note from the customer attached to the sample stated picc was inserted in the basilic vein.Additional information received 1/24/2023: customer reports the patient had the picc replaced.No other information was provided.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Bd vascular access devices field assurance received a leaking picc for evaluation.A note from the customer attached to the sample stated picc was inserted in the basilic vein.Additional information received 1/24/2023: customer reports the patient had the picc replaced.No other information was provided.
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 4fr d/l powerpicc provena catheter.Usage residues were observed throughout the sample.Needleless injection caps were attached to both luer adapters.Microscopic inspection of the sample did not reveal any damage or evidence of leakage.The molded joint and suture wings appeared well-formed and unremarkable.Attempts to infuse water through both luers with and without the injection caps revealed both lumens to be patent to infusion and aspiration with no observed leaks.No leaks were observed during pressurization of the sample.No leaks or damage were observed during functional and microscopic examination of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: DOT PROV 4F DL FULL 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16261233
• Report Number: 3006260740-2023-00192
• Device Sequence Number: 4880757
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Model Number: N/A
• Device Catalogue Number: S1274108
• Device Lot Number: REGU0941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/28/2023
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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 Age: 16 YR
• Patient Sex: Female