inforMED
MalfunctionIFP

FORMALIN JAR

Received Feb 9, 2023 · Event occurred Jan 11, 2023

Report 16333785 · MDR key 16333785

Device

Generic name

Formalin, Neutral Buffered

Model number

EKI4499100X60

Lot number

2215441

Product problems

  • Crack
  • Product Quality Problem

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

LID CRACKING WITH MINIMAL TWISTING. WE HAVE HAD ANOTHER INCIDENCE TODAY WITH SAME LOT NUMBER. WE ORDER THEM THROUGH OUR MEDLINE DISTRIBUTOR. COMPANY NAME ON BOTTLE; EKI (1-800-283-4244). MANUFACTURER RESPONSE FOR FORMALIN JAR, FORMALIN JAR (PER SITE REPORTER) REQUESTED MANUFACTURER ITEM# FROM SITE, ASKED [REDACTED NAME] TO RETRIEVE, PULLED TRACKER REPORT FOR FORMALIN JARS. CC'D [REDACTED NAME] AND ASKED IF HE WOULD BE THE VAN TO EVALUATE NEW PRODUCTS DUE TO ALL OF THE ISSUES WITH THESE (BUGS IN JARS, CRACKED LIDS, QUALITY ISSUES). [REDACTED DATE]- SAMPLE RETRIEVED. [REDACTED DATE]- EMAILED [REDACTED NAME], MEDLINE. [REDACTED DATE]- EMAIL SENT TO EKI REP.; EKI REP RESPONSE RECEIVED AND WILL TAKE ACTION.