STATLOCK INTRA AORTIC BALLOON STABILIZATION DEVICE
Received May 21, 2021 · Event occurred Apr 9, 2021
Report 3006260740-2021-01936 · MDR key 11865542
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
IB0200
Lot number
JUDQF294
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
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 JUDQF294 SHOWED FIVE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.
Description of Event or Problem
IT WAS REPORTED "DURING USE ON THE PATIENT, THE REGISTERED NURSE (RN) PLACED THE STATLOCK STABILIZATION DEVICE ON THE PATIENT. IT WAS NOTED THAT THE PAD ON THE STATLOCK WAS NOT STICKING ON THE PATIENT AND THE RN STATED THE PAD WAS "DRY". SIX STATLOCK WERE USED AND NONE WAS STICKING ON THE PATIENT. AS A RESULT, THE RN CONTINUED TO USE THE NON-STICK STATLOCK AS IS. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH" THIS REPORT ADDRESSES THE SECOND OF SIX DEVICES.