HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER
Report
- Report Number
- 3006260740-2025-06011
- Event Type
- Injury
- Date Received
- August 21, 2025
- Date of Event
- January 27, 2019
- Report Date
- September 9, 2025
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- LJS
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: KATHRYN LARUSSO, GERALDINE SCHAACK, TIFFANY FUNG, KEVIN MCGREGOR, JUSTIN LONG, MARIE-PIER DUMAS ET AL. SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE. JOURNAL OF PEDIATRIC SURGERY, 2019 MAY;54(5):999-1004. DOI: 10.1016/J.JPEDSURG.2019.01.052. THE INITIAL MDR WAS INADVERTENTLY SUBMITTED WITH A G3 DATE OF 07/28/2025. THE CORRECT G3 DATE IS 08/06/2025. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED INFECTION, THROMBOSIS AND STENOSIS ISSUES AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D1, D4 (MEDICAL DEVICE CATALOG #), G1, G3, H6 (COMPONENT). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
H11: KATHRYN LARUSSO, GERALDINE SCHAACK, TIFFANY FUNG, KEVIN MCGREGOR, JUSTIN LONG, MARIE-PIER DUMAS ET AL. SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE. JOURNAL OF PEDIATRIC SURGERY, 2019 MAY;54(5):999-1004. DOI: 10.1016/J.JPEDSURG.2019.01.052 AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL 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.
IT WAS REPORTED IN THE JOURNAL "JOURNAL OF PEDIATRIC SURGERY" ARTICLE TITLED, "SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE", THAT SOMETIME POST CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE BY USING BARD BROVIAC CATHETER TO EVALUATE AND COMPARE THE OUTCOMES OF PERIPHERALLY INSERTED CENTRAL CATHETER TO BROVIAC, PATIENT DEVELOPED WITH CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION, THROMBOSIS AND STENOSIS. IT WAS FURTHER REPORTED THAT THE PATIENTS REQUIRED HOSPITAL ADMISSION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
IT WAS REPORTED IN THE JOURNAL "JOURNAL OF PEDIATRIC SURGERY" ARTICLE TITLED, "SHOULD YOU PICK THE PICC? PROLONGED USE OF PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN CHILDREN WITH INTESTINAL FAILURE", THAT SOMETIME POST CENTRAL VENOUS CATHETER PLACEMENT PROCEDURE BY USING BARD BROVIAC CATHETER TO EVALUATE AND COMPARE THE OUTCOMES OF PERIPHERALLY INSERTED CENTRAL CATHETER TO BROVIAC, PATIENT DEVELOPED WITH CENTRAL LINE ASSOCIATED BLOOD STREAM INFECTION, THROMBOSIS AND STENOSIS. IT WAS FURTHER REPORTED THAT THE PATIENTS REQUIRED HOSPITAL ADMISSION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2203709 | HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER | CHRONIC CATHETERS | LJS | C.R. BARD, INC. (BASD) -3006260740 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |