Safe-T 4301CSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403107771), received between May 26, 2022 and Nov 10, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 20, 2022Open, Classified

   Due to lumbar puncture tray manometer failure mode of leaking and mating issues.

   Z-0794-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THERE'S BEEN AN INTERMITTENT ISSUE WITH THE 25G X 1' NEEDLE IN THESE TRAYS TYPICALLY WE ARE ABLE TO DRAW BACK AIR AND THEN IT WILL WORK. THE ONE IN THIS TRAY DID NOT FUNCTION I WASN'T ABLE TO ASPIRATE AIR INTO THE SYRINGE OR ABLE PUSH AIR OUT THROUGH THE 25G. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE'S BEEN AN INTERMITTENT ISSUE WITH THE 25G X 1' NEEDLE IN THESE TRAYS TYPICALLY WE ARE ABLE TO DRAW BACK AIR AND THEN IT WILL WORK. THE ONE IN THIS TRAY DID NOT FUNCTION I WASN'T ABLE TO ASPIRATE AIR INTO THE SYRINGE OR ABLE PUSH AIR OUT THROUGH THE 25G

  Patient problems: Insufficient Information

  MAUDE report 18114833 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT THIS ISSUE HAS BEEN PRESENT FOR THE PAST 6-8 WEEKS WE THINK IT WAS THE SAME TIME THAT THE LIDOCAINE WAS NOT INCLUDED IN THE TRAY. THE PROVIDED BD SAFETYGLIDE NEEDLE 25 G X 1' HAS BEEN OCCLUDED AND WE ARE UNABLE TO SQUIRT THE AIR OUT OF THE SYRINGE/PRIME THE NEEDLE WITH LIDOCAINE. OTHER TIMES IT IS DIFFICULT BUT THEN IF YOU DRAW MORE AIR INTO THE SYRINGE WITH THE NEEDLE ATTACHED THEN IT WILL PRIME AS USUAL OR WITH SLIGHT DIFFICULTY. IT HAS BEEN INCONSISTENT AMONGST THE TRAYS. THE PROVIDED LOT NUMBER IS FROM A TRAY TODAY 4/20 THAT THIS ISSUE WAS PRESENT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS ISSUE HAS BEEN PRESENT FOR THE PAST 6-8 WEEKS WE THINK IT WAS THE SAME TIME THAT THE LIDOCAINE WAS NOT INCLUDED IN THE TRAY. THE PROVIDED BD SAFETYGLIDE NEEDLE 25 G X 1' HAS BEEN OCCLUDED AND WE ARE UNABLE TO SQUIRT THE AIR OUT OF THE SYRINGE/PRIME THE NEEDLE WITH LIDOCAINE. OTHER TIMES IT IS DIFFICULT BUT THEN IF YOU DRAW MORE AIR INTO THE SYRINGE WITH THE NEEDLE ATTACHED THEN IT WILL PRIME AS USUAL OR WITH SLIGHT DIFFICULTY. IT HAS BEEN INCONSISTENT AMONGST THE TRAYS.

  Patient problems: Insufficient Information

  MAUDE report 18112133 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN ATTEMPTING TO DRAW BACK AND PRIME INCLUDED BD SAFETY GLIDE 25G X 1' NEEDLE WITH LIDOCAINE UNABLE TO ASPIRATE AIR THROUGH NEEDLE UNABLE TO EXPEL AIR OR PRIME NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 18111907 ↗
• MalfunctionNov 10, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE USED FOR LIDOCAINE ADMINISTRATION FOR LP WAS OCCLUDED. UNABLE TO PUSH AIR OR LIDOCAINE THROUGH.

  Patient problems: Insufficient Information

  MAUDE report 18111758 ↗
• MalfunctionNov 10, 2023Contamination; Contamination

  IT WAS REPORTED BY THE CUSTOMER THAT TUBE/VILE #1 PROVIDED IN THIS LUMBAR PUNCTURE KIT HAD A FOREIGN BODY (FB) IN IT. INITIALLY, CUSTOMER THOUGHT IT WAS JUST THE WAY THE TUBES LOOK DUE TO LIGHT REFLECTING. THEN AS CSF BEGAN TO COLLECT THE FOREIGN BODY BEGAN TO FLOAT AND APPEARS AS A BLACK SPECK OF DEBRIS. THE FB THEN SINKS AND CAN BE SEEN AT THE VERY BOTTOM OF THE TUBE. CENTRAL PROCESSING WAS MADE AWARE AND A SPECIMEN NOTE WAS ENTERED IN NOTING THE PRESENCE OF THE FOREIGN BODY AND THAT THIS TUBE SHOULD BE STORED/KEPT AND NOT UTILIZED FOR TESTING UNLESS ABSOLUTELY NECESSARY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. TUBE/VILE #1 PROVIDED IN THIS LUMBAR PUNCTURE KIT HAD A FOREIGN BODY (FB) IN IT. INITIALLY, I THOUGHT IT WAS JUST THE WAY THE TUBES LOOK DUE TO LIGHT REFLECTING. THEN AS CSF BEGAN TO COLLECT THE FB BEGAN TO FLOAT AND APPEARS AS A BLACK SPECK OF DEBRIS. THE FB THEN SINKS AND CAN BE SEEN AT THE VERY BOTTOM OF THE TUBE. CENTRAL PROCESSING WAS MADE AWARE AND A SPECIMEN NOTE WAS ENTERED IN NOTING THE PRESENCE OF THE FOREIGN BODY AND THAT THIS TUBE SHOULD BE STORED/KEPT AND NOT UTILIZED FOR TESTING UNLESS ABSOLUTELY NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 18111131 ↗
• InjuryNov 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED BY THE CUSTOMER THAT THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THEY WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE THREE-WAY STOPCOCK FROM LP TRAY WITH LOT # 0001450952 - THE STOPCOCK WAS OCCLUDED OR THE HOLES THAT ALLOW THE FLUID TO FLOW WERE NON-PATENT AS THE CSF HAD SPONTANEOUS AND CONSISTENT FLOW WITHOUT ANY DIFFICULTY BUT THE WOULD NOT FILL THE STOPCOCK AS USUAL AND THEREFORE WOULD NOT FLOW THROUGH AND ALLOW FOR PRESSURE MEASUREMENT WITH THE INCLUDED MANOMETER BUT THE CSF WOULD ALSO NOT FLOW OUT THE OPEN PORT OF THE STOPCOCK. LOT # 0001452437 - LEAKED UNABLE TO OBTAIN ACCURATE PRESSURE FURTHER DETAILS COULD BE OBTAINED FROM XXX

  Patient problems: Insufficient Information

  MAUDE report 18111016 ↗
• MalfunctionMay 26, 2022Contamination; Contamination

  IT WAS REPORTED BY CUSTOMER BLACK SPECKS ARE NOTED IN THE TUBES. VERBATIM: SRG - VH - 4301CSP - LOT:0001451109 - BLACK SPECKS ARE NOTED IN THE TUBES. THIS IS THE THIRD TRAY THAT THEY CAUGHT HAVING THE SPECKS IN THE FLUID BUT THIS ONE WAS CAUGHT BEFORE IT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519027 ↗