BD SCRUB BRUSH E-Z SCRUB DRY STERILE
Received Jun 1, 2020 · Event occurred May 7, 2020
Report 1710034-2020-00340 · MDR key 10105599
Device
Generic name
Scrub Brush
Manufacturer
Becton Dickinson Infusion Therapy Systems Inc.Model number
371603Catalog number
371603
Lot number
9184663
Product problems
- Packaging Problem
- Packaging Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT 2 PACKAGES WERE DIFFICULT TO OPEN PRIOR TO USE AND WOULD RIP WITH A BD SCRUB BRUSH E-Z¿ SCRUB¿ DRY STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 X PACKETS WERE DIFFICULT TO OPEN AND CAUSED RIPPING.
Description of Event or Problem
IT WAS REPORTED THAT 2 PACKAGES WERE DIFFICULT TO OPEN PRIOR TO USE AND WOULD RIP WITH A BD SCRUB BRUSH E-Z¿ SCRUB¿ DRY STERILE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 X PACKETS WERE DIFFICULT TO OPEN AND CAUSED RIPPING.
Additional Manufacturer Narrative
TWO SAMPLES RECEIVED. UNABLE TO OPEN EITHER SAMPLE, ALTHOUGH THE CUSTOMER HAD TRIED TO. COMPLAINT CONFIRMED. THE MOST LIKELY CAUSE WOULD BE FROM THE PACKAGING MACHINE STOPPING, AND RESIDUAL HEAT FROM THE SEALING DIE LOCALLY PRODUCING A SEAL THAT WAS TOO STRONG. ONE PRIOR COMPLAINT IN 2007 DHR REVIEWED. SEAL PEEL STRENGTH IS ONE OF THE CHARACTERISTICS MEASURE. ALL MEASUREMENTS WERE IN CONTROL LIMITS. H3 OTHER TEXT : SEE H.10.