BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED
Received Aug 25, 2023 · Event occurred Jul 28, 2023
Report 1119779-2023-00946 · MDR key 17627442
Device
Generic name
Tube, Collection, Capillary Blood
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
420317
Lot number
UNKNOWN
Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED THAT THERE WAS LEAKING/BROKEN BOTTLE CONTAINING PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES - STOCKING ITEM END USER IS STATING THAT THE BLOOD IS BEING SPILL OUT OF THE TUBE.
Additional Manufacturer Narrative
EVENT DESCRIPTION: "CUSTOMER STATES - STOCKING ITEM END USER IS STATING THAT THE BLOOD IS BEING SPILL OUT OF THE TUBE.¿ COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: THE REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. SAMPLE ANALYSIS: NO RETURNS OR PHOTOS WERE AVAILABLE. AN INSPECTION OF THE RETENTION SAMPLES COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. NO COMPLAINT TREND HAS BEEN OBSERVED. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD SUREPREP¿ CAPILLARY TUBES- HEPARINIZED THAT THERE WAS LEAKING/BROKEN BOTTLE CONTAINING PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES - STOCKING ITEM END USER IS STATING THAT THE BLOOD IS BEING SPILL OUT OF THE TUBE.
Additional Manufacturer Narrative
D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.6 INITIAL REPORTER E-MAIL: (B)(6). H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.