STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
Received Jul 7, 2021 · Event occurred Nov 12, 2020
Report 3006260740-2021-02629 · MDR key 12132317
Device
Generic name
Introducer, Catheter
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
PIC0220CE
Lot number
JUEP1033
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A STATLOCK RETAINER DETACHMENT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. THREE PHOTO SAMPLES OF A STATLOCK SECUREMENT DEVICE WERE PROVIDED FOR EVALUATION. THE STATLOCK ADHESIVE PAD IS SHOWN TO BE ATTACHED TO THE PATIENT¿S RIGHT ARM NEAR THE CATHETER INSERTION SITE. THE CATHETER IS SECURED WITHIN THE DETACHED RETAINER AND IS BEING HELD BY THE CLINICIAN. ONE OF THE PHOTOS SHOWS A STATLOCK PICC PLUS KIT. THE PRODUCT LABEL INFORMATION INDICATES LOT: JUEP1033. THE CONDITIONS OF USE ARE UNKNOWN. BASED ON THE DESCRIPTION OF THE REPORTED EVENT, POSSIBLE CONTRIBUTING FACTORS INCLUDE DAMAGE DURING HANDLING AND MATERIAL DEGRADATION. SINCE THE RETAINER WAS OBSERVED TO BE DETACHED, THE COMPLAINT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
Description of Event or Problem
IT WAS REPORTED THAT THE NURSE WHILE CHANGING THE STATLOCK, REMOVED AND PULLED THE PICC LINE ATTACHED TO THE STATLOCK FROM THE PATIENT. THE PICC WAS REMOVED AND REPLACED WITH NEW ONE.
Additional Manufacturer Narrative
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUEP1033 SHOWED NO SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT THE NURSE WHILE CHANGING THE STATLOCK, REMOVED AND PULLED THE PICC LINE ATTACHED TO THE STATLOCK FROM THE PATIENT. THE PICC WAS REMOVED AND REPLACED WITH NEW ONE. ON (B)(6) 2021 - CLARIFICATION RECEIVED THAT THIS EVENT IS FOR 1 OCCURRENCE.