inforMED
InjuryBSP

N/A

Received May 6, 2024 · Event occurred Mar 27, 2024

Report 19248236 · MDR key 19248236

Device

Generic name

Needle, Conduction, Anesthetic (w/wo Introducer)

Model number

405161

Catalog number

405161

Lot number

3059930, 3209684

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

EVENT #1 [REDACTED DATE]: UNABLE TO ADMINISTER INTRATHECAL CHEMOTHERAPY. ALL, DAY 24 CONSOLIDATION LUMBAR PUNCTURE WITH IT HC/MTX UNDER DEEP SEDATION, UNABLE TO SAFELY CONNECT CHEMOTHERAPY SYRINGE TO LP NEEDLE, CHEMOTHERAPY SYRINGE COMPROMISED OUTSIDE OF STERILE FIELD. THE PLASTIC HUB OF 22G, 1.5 INCH LP NEEDLE SLIGHTLY MISSHAPED AT SEAM. REF 405161, LOT 3059930. EVENT #2 [REDACTED DATE]: SITUATION: DEFECTIVE PRODUCT IDENTIFIED BY DR. BACKGROUND: STYLET OF SPINAL NEEDLE FOUND TO BE EXTENDING PAST THE END OF THE NEEDLE DURING THE PRE-LP CHECKS. THIS DEFECTIVE PRODUCT WAS NOT DIRECTLY USED ON THE PATIENT. ASSESSMENT: BD REF 405181, LOT3209684. SINGLE DEFECTIVE NEEDLE FOUND AT THIS TIME (PROVIDER SPOT CHECKED A FEW OTHERS). RECOMMENDATION: DR. [REDACTED NAME] HAS CONCERNS ABOUT THE OVERALL QUALITY OF BD PRODUCTS GIVEN THIS EVENT REPORT. LOT 3209684, REF 405181.