MalfunctionFOX

STATLOCK CV PLUS SLIDING POST

Received Feb 26, 2021 · Event occurred Jan 18, 2021

Report 3006260740-2021-00542 · MDR key 11388703

Device

Generic name

Stand, Infusion

Manufacturer

C.r. Bard, Inc. (basd) -3006260740

Model number

N/A

Catalog number

CV0220CE

Lot number

JUDZ0833

Product problems

Loose or Intermittent Connection

Narrative

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUDZ0833 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT ON (B)(6) 2021, AFTER ADMISSION, THE PATIENT UNDERWENT PICC MAINTENANCE AND OPENED THE CATHETER FIXATOR. THE CLASP WAS FOUND LOOSE DURING USE, AND THE CATHETER FIXATOR WAS IMMEDIATELY REPLACED WITHOUT ADVERSE CONSEQUENCES.