STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP
Received May 6, 2024 · Event occurred Apr 16, 2024
Report 3006260740-2024-02182 · MDR key 19249125
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
VPPCSPCE
Lot number
JUHX1847
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Unspecified Infection
- Contact Dermatitis
- Unspecified Infection
- Contact Dermatitis
Narrative
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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON.
Description of Event or Problem
IT WAS REPORTED, SKIN INJURY IN A PATIENT OF THE AMBULATORY ONCOLOGY SERVICE ASSOCIATED WITH THE USE OF THE PRODUCT "STATLOCK PICC" (REFERENCE VPPCSPCE) LOT: JUHX1847 (EXPIRATION 2026). AS POINTED OUT BY THE COLLEAGUE, THE PRODUCT IS BEING REPLACED IN THE HEALING PROCESS OF THE PICC CATHETER ACCORDING TO THE FACTORY RECOMMENDATION (EVERY 7 DAYS). NO OTHER INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED, SKIN INJURY IN A PATIENT OF THE AMBULATORY ONCOLOGY SERVICE ASSOCIATED WITH THE USE OF THE PRODUCT "STATLOCK PICC" (REFERENCE VPPCSPCE) LOT: JUHX1847 (EXPIRATION 2026). AS POINTED OUT BY THE COLLEAGUE, THE PRODUCT IS BEING REPLACED IN THE HEALING PROCESS OF THE PICC CATHETER ACCORDING TO THE FACTORY RECOMMENDATION (EVERY 7 DAYS). NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED (B)(6) 2024: IT WAS REPORTED PATIENT IMPACT: DERMATITIS AND USE OF ANTIBIOTICS.
Additional Manufacturer Narrative
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.
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 COMPLAINT OF A SKIN REACTION IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF A STATLOCK DEVICE WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED A STATLOCK DEVICE ON A PATIENT¿S ARM. THE STATLOCK DEVICE WAS OBSERVED TO BE PARTLY REMOVED FROM THE PATIENT¿S SKIN IN THE PHOTOGRAPH. THE AREA OF THE PATIENT¿S SKIN UNDERNEATH THE STATLOCK DEVICE WAS OBSERVED TO BE INJURED WITH MANY SORES AND SOME REDNESS. WHILE A SKIN REACTION CAN BE CONFIRMED, THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPH OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.
Description of Event or Problem
IT WAS REPORTED, SKIN INJURY IN A PATIENT OF THE AMBULATORY ONCOLOGY SERVICE ASSOCIATED WITH THE USE OF THE PRODUCT "STATLOCK PICC" (REFERENCE VPPCSPCE) LOT: JUHX1847, (EXPIRATION 2026). AS POINTED OUT BY THE COLLEAGUE, THE PRODUCT IS BEING REPLACED IN THE HEALING PROCESS OF THE PICC CATHETER ACCORDING TO THE FACTORY RECOMMENDATION (EVERY 7 DAYS). NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 10 MAY 2024: IT WAS REPORTED PATIENT IMPACT: DERMATITIS AND USE OF ANTIBIOTICS.