MalfunctionFOX
STATLOCK POSTED NEONATE PAD INCLUDES SALINE WIPE
Received Sep 22, 2021 · Event occurred Sep 2, 2021
Report 3006260740-2021-03927 · MDR key 12517151
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
NN0200
Lot number
JUEP1098
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEP1098 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT NEONATAL STATLOCK PLASTIC POSTS ARE NOT ADHERED TO THE ADHESIVE PAD. THE POSTS STARTED TO LET GO AFTER APPLYING TO THE PATIENT WHICH ALMOST RESULTED IN A LINE MIGRATION IN A NEONATE, A SIGNIFICANT SAFETY RISK.