inforMED
MalfunctionISR

SECURLINE

Received Oct 30, 2019 · Event occurred Sep 18, 2019

Report 9255583 · MDR key 9255583

Device

Generic name

Band Or Belt, Pelvic Support

Catalog number

2403-14-PDB

Lot number

8655438

Product problems

  • Device Markings/Labelling Problem

Patient

26645 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WE CURRENT USE PRECISION DYNAMICS CORPORATION SECURLINE BLOOD BANDS. SEVERAL OF THE ARMBANDS CONTAINED 2 DISTINCT NUMBERS, WHEN THE BAND SHOULD ONLY HAVE ONE NUMBER. THESE BANDS ARE USED TO IDENTIFY ALL OUR PATIENTS WHO ARE TO RECEIVE BLOOD AND BLOOD PRODUCTS AND THIS DEFECT COULD POTENTIALLY LEAD TO THE INCORRECT PATIENT RECEIVING BLOOD OR A PATIENT RECEIVING THE INCORRECT BLOOD TYPE. TWO PATIENTS HAD TO BE REDRAWN AND RE-BANDED PRIOR TO RECEIVING BLOOD. MANUFACTURER RESPONSE FOR ARMBAND, SECURLINE BLOOD BAND (PER SITE REPORTER). THEY HAVE REQUESTED ADDITIONAL INFORMATION AND PICTURES OF THE PRODUCT DEFECT.