HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER
Report
- Report Number
- 3006260740-2025-06113
- Event Type
- Injury
- Date Received
- August 22, 2025
- Date of Event
- July 28, 2025
- Report Date
- October 27, 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
- HK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: WONG W, CHAN W, IP S, NG W, CHAN C, HO H, SIU K, TAN C. INFECTION RATE OF HICKMAN CATHETERS VERSUS PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN ONCOLOGY PATIENTS. HONG KONG J RADIOL. 2015 SEP 1;18:197-204. DOI: 10.12809/HKJR1514289. 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 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: WONG W, CHAN W, IP S, NG W, CHAN C, HO H, SIU K, TAN C. INFECTION RATE OF HICKMAN CATHETERS VERSUS PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN ONCOLOGY PATIENTS. HONG KONG J RADIOL. 2015 SEP 1; 18:197-204. DOI: 10.12809/HKJR1514289. 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 BLOOD STREAM INFECTION AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. D1, D2, D4 (MEDICAL DEVICE CATALOG #), 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.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "HONG KONG JOURNAL OF RADIOLOGY" TITLED, "INFECTION RATE OF HICKMAN CATHETERS VERSUS PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN ONCOLOGY PATIENTS", THE HICKMAN CATHETER AND POWERPICC WERE USED. OVERALL, 38 CASES IN THE HICKMAN GROUP AND 4 CASES IN THE PICC GROUP HAD CATHETER RELATED BLOOD STREAM INFECTION. NON-INFECTIOUS COMPLICATIONS INCLUDED BLOCKAGE IN 6 HICKMAN AND 3 PICC PATIENTS, DISLODGEMENT/MIGRATION IN 4 HICKMAN AND 3 PICC PATIENTS, LEAKAGE/PERFORATION 5 HICKMAN PATIENTS.
IT WAS REPORTED IN AN ARTICLE IN THE JOURNAL "HONG KONG JOURNAL OF RADIOLOGY" TITLED, "INFECTION RATE OF HICKMAN CATHETERS VERSUS PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS IN ONCOLOGY PATIENTS", THE HICKMAN CATHETER AND POWERPICC WERE USED. OVERALL, 38 CASES IN THE HICKMAN GROUP AND 4 CASES IN THE PICC GROUP HAD CATHETER RELATED BLOOD STREAM INFECTION. NON-INFECTIOUS COMPLICATIONS INCLUDED BLOCKAGE IN 6 HICKMAN AND 3 PICC PATIENTS, DISLODGEMENT/MIGRATION IN 4 HICKMAN AND 3 PICC PATIENTS, LEAKAGE/PERFORATION 5 HICKMAN PATIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2395973 | HICKMAN/LEONARD/BROVIAC CENTRAL VENOUS CATHETER | CENTRAL VENOUS CATHETER | LJS | C.R. BARD, INC. (BASD) -3006260740 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |