APTIMA SPECIMEN COLLECTION DEVICE
Received May 18, 2017 · Event occurred Apr 21, 2017
Report 2024800-2017-00014 · MDR key 6575650
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Bowel Perforation
- Bowel Perforation
Narrative
Additional Manufacturer Narrative
HOLOGIC FOLLOWED UP SEVERAL TIMES WITH REPORTER BUT NO INFORMATION WAS AVAILABLE IF AND WHERE THIS ISSUE ACTUALLY OCCURRED.
Description of Event or Problem
HOLOGIC RECEIVED AN EMAIL NOTIFICATION FROM (B)(6) ON 21APR2017 WHO RECEIVED AN EMAIL FROM (B)(6), A LEAD NURSE AT (B)(6) (B)(6) INDICATING THAT THERE WAS REPORTS OF BOWEL PERFORATION WHEN USING THE PURPLE APTIMA (B)(6) SWABS. ACCORDING TO THE EMAIL COMMUNICATION, THE INCIDENT DID NOT OCCUR AT THE (B)(6) SITE BUT AT ANOTHER UNKNOWN CLINIC. THE REPORTED INFORMATION STATED THAT CUSTOMER USED THE APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT OFF PACKAGE INSERT (PI) INSTRUCTIONS BY TAKING RECTAL SAMPLES. THE CUSTOMER ACKNOWLEDGES THE USE IS OFF PI INSTRUCTIONS AND HAS REMINDED THEIR TEAM NOT TO USE THESE TUBES. HOLOGIC FOLLOWED UP WITH (B)(6) TEACHING HOSPITALS TO GET MORE INFORMATION ON THE REPORTED INCIDENT(S) BUT AS THE INCIDENT HAD NOT OCCURRED AT THEIR HOSPITAL, THEY HAVE NO FURTHER DETAILS AND COULD NOT CONFIRM THE OCCURRENCE OR LOCATION OF THIS INCIDENT. THERE HAVE BEEN NO OTHER REPORTS OF THIS NATURE TO HOLOGIC.