UNKNOWN
Received Feb 2, 2021 · Event occurred Oct 9, 2020
Report 3008258694-2021-00006 · MDR key 11270425
Device
Product problems
- Device Damaged Prior to Use
- Manufacturing, Packaging or Shipping Problem
- Device Damaged Prior to Use
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS WAS IDENTIFIED AT A TRAINING OPERATION WITHIN THE US MILITARY. NO PATIENT INVOLVEMENT. REFERENCE MDR NO. 3008258694-2021-00001. INITIAL MDR ASSESSMENT WAS COMPLETED AND DETERMINED NOT TO BE REPORTABLE BASED ON CUSTOMER USAGE (TRAINING EXERCISE) AND NO PATIENT IMPACT. HOWEVER, A FIELD ACTION WAS INITIATED AND IN AN ABUNDANCE OF CAUTION WE REEVALUATED OUR MDR ASSESSMENT AND ARE FILING THIS REPORT. COMBAT MEDICAL RECEIVED A COMPLAINT THAT THE BLOOD PACK NEEDLE WERE FOUND BENT UPON OPENING THE CONVENIENCE KIT. THE ISSUE WAS DISCOVERED TO BE ONE COMPONENT (A STAND ALONE DEVICE) WITHIN THE CONVENIENCE KIT: BLOOD PACK, SINGLE UNIT, R80-808. INVESTIGATION HAS SHOWN THAT THE CURRENT ASSEMBLY PROCESS HAS THE POTENTIAL OF BENDING/DISCONNECTING THE NEEDLES USED IN THE AFFECTED KITS. THE INFLUENCE OF THE VARIATION OF THE NEEDLE POSITION WITHIN THE COMPONENT (BLOOD PACK, SINGLE UNIT, 450 ML (R80-808)), COUPLED WITH THE MANUAL ASSEMBLY PROCESS OF FOLDING THE BLOOD PACK IS CAUSING NEEDLE DAMAGE IN THE FINISHED PRODUCT.
Description of Event or Problem
KIT COMPONENT, BLOOD PACK 450ML LOT NUMBER FM20E27024, HAD A BENT NEEDLE WHEN KIT WAS OPENED.
Remedial action
- Recall