SECURLINE
Received Oct 30, 2019 · Event occurred Sep 18, 2019
Report 9255583 · MDR key 9255583
Device
Generic name
Band Or Belt, Pelvic Support
Manufacturer
Precision Dynamics CorporationCatalog 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.