inforMED
OFF

CENTRAL LINE<34 WEEKS KIT

Received May 27, 2015 · Event occurred May 5, 2015

Report 4840103 · MDR key 4840103

Device

Generic name

Central Line Kit

Model number

*

Catalog number

DYN1987A

Lot number

14DB9277

Product problems

  • Off-Label Use

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WE HAVE 2 CENTRAL LINE KITS THAT ARE LABELED AS THE SAME PRODUCT, BOTH ARE LABELED "<34 WEEK KIT", BUT THE KITS HAVE 2 DIFFERENT REFERENCE NUMBERS AND CONTAIN DIFFERENT PRODUCTS. THE KIT WITH REFERENCE NUMBER: (B)(4) KIT DOES NOT HAVE CHG (CHLORHEXIDINE GLUCONATE) AND THE KIT WITH REFERENCE NUMBER: (B)(4) CONTAINS CHG (BIOPATCH). STAFF COULD PICK A KIT AND IT WOULD CONTAIN CHG--THAT SHOULD NOT BE USED FOR PREEMIES LESS THAN 34 WEEKS.