POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN
Report
- Report Number
- 3006260740-2021-05535
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- October 15, 2021
- Report Date
- January 26, 2022
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- FPA
- PMA / PMN Number
- K153440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
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, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING INFUSION SET WAS CONFIRMED AND THE CAUSE IS CURRENTLY UNDER INVESTIGATION. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 20GA X 0.75" POWERLOC MAX SAFETY INFUSION SET. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND THE FOLLOWING OBSERVATIONS WERE MADE: THE FRACTURE SURFACES OF THE DAMAGE CONTAINED STRIATION-LIKE PATTERNS, RADIATING TEAR MARKS AND MATERIAL DEFORMATION WHICH WERE INDICATIVE OF FLEXURAL FATIGUE BASED FAILURES, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE EXTENSION TUBING DAMAGE. REPETITIVE MECHANICAL STRESSES SUCH AS TWISTING AND KINKING MAY HAVE CONTRIBUTED TO THE OBSERVED EVENT; HOWEVER, IT APPEARED THAT ADDITIONAL UNIDENTIFIED FACTORS ALSO CONTRIBUTED. THE DEVICE IS A SUPPLIED COMPONENT AND THE SUPPLIER HAS BEEN NOTIFIED OF THIS EVENT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
IT WAS REPORTED "PERFORMING PATIENT CARE AND NOTICED LEAKING FROM PORT SITE. PATIENT'S PANTS WERE WET & HAD SMEARS OF BLOOD ON THEM. TRACED HIS TUBING AND DISCOVERED A BREAK IN THE PORT TUBING WHERE PATIENT'S IVMF AND REVERSE BLOOD IN THE LINE WAS LEAKING FROM. I DE-ACCESSED THE PATIENT, COLLECTED THE DAMAGED PORT FOR REFERENCE, AND RE-ACCESSED THE PATIENT. NO HARM WAS DONE TO THE PATIENT." ADDITIONAL QUESTIONS ASKED OF RN: WAS ANOTHER NEEDLE/ACCESS REQUIRED? YES, HAD TO RE-ACCESS PORT WITH A NEW NEEDLE. DID THE PATIENT HAVE ANY SYMPTOMS DUE TO THE BREAK/LEAK, I.E. BLOOD LOSS, LABS DRAWN, ETC.? NO. WAS THE PROVIDER NOTIFIED OF THE EVENT? NO. WAS THERE ADDITIONAL TREATMENTS REQUIRED DUE TO PRODUCT FAILURE, I.E. TRANSFUSION, ETC.? NO. WAS THERE ANY EXTRAVASATION OR INFILTRATION IDENTIFIED? NO. WHAT WAS INFUSING AT THE TIME OF THE PRODUCT FAILURE? IV MAINTENANCE FLUIDS. WAS THERE A POSSIBILITY OR SIGNS/SYMPTOMS OF INFILTRATION AT THE PORT SITE? NO. DID THE VOLUME OF THE LEAK CAUSE THE MEDICATION TO BE RE-DOSED BY PHARMACY? NO, NO MEDICATION WAS INFUSING. HOW WAS THE SPILL/LEAK CONTAINED AND HANDLED? I PAUSED HIS MAINTENANCE FLUIDS, WIPED DOWN THE PATIENT WITH BATH WIPES, AND CHANGED HIS CLOTHING. WAS THERE A LINE-GUARD IN PLACE SECURING THE TUBING BELOW THE DRESSING , PRIOR TO THE PRODUCT FAILURE? YES. DID THIS EVENT OCCUR WHEN THE PATIENT WAS SEDENTARY OR MOBILE? PATIENT WAS MOBILE. CAN YOU TELL ME HOW LONG THIS PATIENT HAD BEEN ACCESSED WITH THIS PARTICULAR NEEDLE, PRIOR TO THE PRODUCT FAILURE? ORIGINALLY ACCESSED 10/14/21 @ 1800, SO 1 DAY. WHAT WAS THE AGE OF THIS PATIENT? (B)(6).
IT WAS REPORTED "PERFORMING PATIENT CARE AND NOTICED LEAKING FROM PORT SITE. PATIENT'S PANTS WERE WET & HAD SMEARS OF BLOOD ON THEM. TRACED HIS TUBING AND DISCOVERED A BREAK IN THE PORT TUBING WHERE PATIENT'S IVMF AND REVERSE BLOOD IN THE LINE WAS LEAKING FROM. I DE-ACCESSED THE PATIENT, COLLECTED THE DAMAGED PORT FOR REFERENCE, AND RE-ACCESSED THE PATIENT. NO HARM WAS DONE TO THE PATIENT." ADDITIONAL QUESTIONS ASKED OF RN: 1. WAS ANOTHER NEEDLE/ACCESS REQUIRED? YES, HAD TO RE-ACCESS PORT WITH A NEW NEEDLE. 2. DID THE PATIENT HAVE ANY SYMPTOMS DUE TO THE BREAK/LEAK, I.E.. BLOOD LOSS, LABS DRAWN, ETC.? NO. 3. WAS THE PROVIDER NOTIFIED OF THE EVENT? NO. 4. WAS THERE ADDITIONAL TREATMENTS REQUIRED DUE TO PRODUCT FAILURE, I.E.. TRANSFUSION, ETC.? NO. 5. WAS THERE ANY EXTRAVASATION OR INFILTRATION IDENTIFIED? NO. 6. WHAT WAS INFUSING AT THE TIME OF THE PRODUCT FAILURE? IV MAINTENANCE FLUIDS. 7. WAS THERE A POSSIBILITY OR SIGNS/SYMPTOMS OF INFILTRATION AT THE PORT SITE? NO. 8. DID THE VOLUME OF THE LEAK CAUSE THE MEDICATION TO BE RE-DOSED BY PHARMACY? NO, NO MEDICATION WAS INFUSING. 9. HOW WAS THE SPILL/LEAK CONTAINED AND HANDLED? I PAUSED HIS MAINTENANCE FLUIDS, WIPED DOWN THE PATIENT WITH BATH WIPES, AND CHANGED HIS CLOTHING. 10. WAS THERE A LINE-GUARD IN PLACE SECURING THE TUBING BELOW THE DRESSING , PRIOR TO THE PRODUCT FAILURE? YES. 11. DID THIS EVENT OCCUR WHEN THE PATIENT WAS SEDENTARY OR MOBILE? PATIENT WAS MOBILE. 12. CAN YOU TELL ME HOW LONG THIS PATIENT HAD BEEN ACCESSED WITH THIS PARTICULAR NEEDLE, PRIOR TO THE PRODUCT FAILURE? ORIGINALLY ACCESSED (B)(6) 2021 @ 1800, SO 1 DAY. 13. WHAT WAS THE AGE OF THIS PATIENT? 11 MONTHS. (B)(6) 2022-MEDWATCH RECEIVED STATED: "HEALTH CARE PROVIDER WAS PERFORMING PATIENT CARE AND NOTICED LEAKING FROM THE PORT SITE OF THE POWERLOC MAX SAFETY INFUSION SET. PATIENT'S PANTS WERE WET & HAD SMEARS OF BLOOD ON THEM. TRACED HIS TUBING AND DISCOVERED A BREAK IN THE PORT TUBING WHERE PATIENT'S IVMF AND REVERSE BLOOD IN THE LINE WAS LEAKING FROM. HEALTH CARE PROVIDER DE-ACCESSED THE PATIENT, COLLECTED THE DAMAGED PORT FOR REFERENCE, AND RE-ACCESSED THE PATIENT. NO HARM WAS DONE TO THE PATIENT. THE PACKAGING FROM THE FAULTY DEVICE WAS DISCARDED FOLLOWING THE INCIDENT."
IT WAS REPORTED "PERFORMING PATIENT CARE AND NOTICED LEAKING FROM PORT SITE. PATIENT'S PANTS WERE WET & HAD SMEARS OF BLOOD ON THEM. TRACED HIS TUBING AND DISCOVERED A BREAK IN THE PORT TUBING WHERE PATIENT'S IVMF AND REVERSE BLOOD IN THE LINE WAS LEAKING FROM. I DE-ACCESSED THE PATIENT, COLLECTED THE DAMAGED PORT FOR REFERENCE, AND RE-ACCESSED THE PATIENT. NO HARM WAS DONE TO THE PATIENT." ADDITIONAL QUESTIONS ASKED OF RN: 1. WAS ANOTHER NEEDLE/ACCESS REQUIRED? YES, HAD TO RE-ACCESS PORT WITH A NEW NEEDLE 2. DID THE PATIENT HAVE ANY SYMPTOMS DUE TO THE BREAK/LEAK, I.E.. BLOOD LOSS, LABS DRAWN, ETC.? NO. 3. WAS THE PROVIDER NOTIFIED OF THE EVENT? NO. 4. WAS THERE ADDITIONAL TREATMENTS REQUIRED DUE TO PRODUCT FAILURE, I.E.. TRANSFUSION, ETC.? NO. 5. WAS THERE ANY EXTRAVASATION OR INFILTRATION IDENTIFIED? NO. 6. WHAT WAS INFUSING AT THE TIME OF THE PRODUCT FAILURE? IV MAINTENANCE FLUIDS 7. WAS THERE A POSSIBILITY OR SIGNS/SYMPTOMS OF INFILTRATION AT THE PORT SITE? NO. 8. DID THE VOLUME OF THE LEAK CAUSE THE MEDICATION TO BE RE-DOSED BY PHARMACY? NO, NO MEDICATION WAS INFUSING. 9. HOW WAS THE SPILL/LEAK CONTAINED AND HANDLED? I PAUSED HIS MAINTENANCE FLUIDS, WIPED DOWN THE PATIENT WITH BATH WIPES, AND CHANGED HIS CLOTHING. 10. WAS THERE A LINE-GUARD IN PLACE SECURING THE TUBING BELOW THE DRESSING , PRIOR TO THE PRODUCT FAILURE? YES. 11. DID THIS EVENT OCCUR WHEN THE PATIENT WAS SEDENTARY OR MOBILE? PATIENT WAS MOBILE. 12. CAN YOU TELL ME HOW LONG THIS PATIENT HAD BEEN ACCESSED WITH THIS PARTICULAR NEEDLE, PRIOR TO THE PRODUCT FAILURE? ORIGINALLY ACCESSED (B)(6) 2021 @ 1800, SO 1 DAY. 13. WHAT WAS THE AGE OF THIS PATIENT? 11 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1571680 | POWERLOC MAX POWER-INJECTIBLE INFUSION SET 20G X 0.75IN | SET, ADMINISTRATION, INTRAVASCULAR | FPA | C.R. BARD, INC. (BASD) -3006260740 | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 MO | Unknown | Other |