DBD-PICC LINE INSERTION PACK
Received Apr 3, 2024 · Event occurred Jan 18, 2023
Report 1423395-2024-00292 · MDR key 19038952
Device
Generic name
Dbd-picc Line Insertion Pack
Manufacturer
Medline Industries, LpCatalog number
DYNJ66654A
Lot number
22KMC332
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THE SYRINGE STOPCOCK HAD AN "OILY SUBSTANCE" ON PLUNGER. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THE SYRINGE STOPCOCK HAD AN "OILY SUBSTANCE" ON PLUNGER.