Safe-T 4306CWSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403229008), received between Mar 17, 2021 and Feb 8, 2023 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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-0800-2022 · 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.

• InjuryFeb 8, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED BY THE CUSTOMER THAT ONE NEEDLE COME NOT PATENT AND A SEPARATE KIT COME WITH THE SPINAL NEEDLE FUSED. VERBATIM: I HAVE HAD A RASH OF FAULTY LUMBAR PUNCTURE KITS AND UNFORTUNATELY ONE YESTERDAY RESULTED IN ME GETTING STUCK WITH A DIRTY NEEDLE. I AM HOPING THAT SOMEONE CAN RESPOND TO THIS ASAP AS THIS WAS NOT AN ISOLATED INCIDENT AND I THINK WE NEED TO CONSIDER AN ALTERNATIVE MANUFACTURER. TWO WEEKS AGO, IN TWO SEPARATE KITS I HAD ONE NEEDLE COME NOT PATENT AND A SEPARATE KIT COME WITH THE SPINAL NEEDLE FUSED. BOTH OF THEM HAD THE SAME LOT NUMBER (LISTED BELOW). YESTERDAY, I RECEIVED A KIT THAT HAD A FOAM NEEDLE STOP THAT WAS NOT ADHERED TO THE BOTTOM OF THE TRAY (SO IT CAME OUT WHEN I PUT A NEEDLE IN IT). I PUT THE PLASTIC CAP FLAT ON THE TRAY AND SLID THE NEEDLE IN. I MOVED THE NEEDLE VERTICALLY TO SECURE THE CAP AND THE CAP POKED THROUGH THE TOP OF THE PLASTIC CAP. THIS KIT WAS THE SAME LOT NUMBER AS THE INCIDENTS LISTED ABOVE. IT IS MY OPINION THAT THIS KIT SHOULD BE REMOVED FROM THE HOSPITAL IMMEDIATELY OR THERE WILL CONTINUE TO BE PEOPLE ACCIDENTLY GETTING POKED. CAN WE PLEASE GET AN ALTERNATIVE MANUFACTURER? THIS WAS A BD/CAREFUSION KIT (LOT 0001482141, EXP 7/3

  Patient problems: Needle Stick/Puncture

  MAUDE report 16326030 ↗
• MalfunctionJan 24, 2023Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  FOAM NEEDLE STOP WAS NOT ADHERED TO THE BOTTOM OF THE TRAY, SO IT CAME OUT WHEN NEEDLE WAS PLACED IN IT. 22-GAUGE NEEDLES IN USE. STAFF MEMBER PUT THE PLASTIC CAP FLAT ON THE TRAY AND SLID THE NEEDLE IN. SHE MOVED THE NEEDLE VERTICALLY TO SECURE THE CAP AND THE CAP POKED THROUGH THE TOP OF THE PLASTIC CAP. EMPLOYEE NEEDLESTICK INJURY OCCURRED. TWO PRIOR INCIDENTS WITH THIS LOT DID NOT RESULT IN EMPLOYEE INJURY. MANUFACTURER RESPONSE FOR LUMBAR PUNCTURE TRAY (ADULT PEDIATRIC), SAFE-T (PER SITE REPORTER). "I WILL BE FORWARDING THIS ON TO OUR FIELD ASSURANCE TEAM. EVEN THOUGH WE ARE NO LONGER SELLING THIS ITEM, WE DO INDEED NEED TO BE MADE OF ANY ADVERSE EVENTS. THANK YOU."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16234216 ↗
• InjuryMay 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED BY CUSTOMER PRODUCT HAS ISSUE. EMAIL VERBATIM: WE HAVE ANOTHER LUMBAR PUNCTURE TRAY CAT# 4306CWSP THAT WE HAD AN ISSUE WITH THAT WAS RELATED TO THE RECENT RECALL. LOT NUMBER 0001424764. IF YOU COULD PLEASE ANSWER THE FOLLOWING QUESTIONS, SO THAT I CAN OPEN UP A NEW COMPLAINT FOR THIS. CAN YOU PLEASE PROVIDE ADDITIONAL DETAILS IN REGARDS TO THE ISSUE? MANOMETER WOULD NOT HOLD PRESSURE AND WAS LEAKING AT CONNECTION BETWEEN TUBING AND MANOMETER. CAN YOU PLEASE PROVIDE THE LOT NUMBER? 0001424764. . CAN YOU PLEASE PROVIDE THE MATERIAL NUMBER? CAT# 4306CWSP. CAN YOU PLEASE PROVIDE THE DATE OF EVENT? (B)(6) 2022. WOULD YOU HAPPEN TO HAVE PHOTOS YOU CAN SHARE? NO PHOTOS. WOULD YOU HAPPEN TO HAVE SAMPLES TO RETURN? IF SO, PLEASE PROVIDE A DIRECT ADDRESS AND PHONE. WE ONLY HAVE ONE CASE WITH THE SAME LOT NUMBER UNOPENED. WHAT WAS THE IMPACT TO THE PATIENT? COULD NOT GET A PRESSURE READING FOR THE PROVIDER. HOW WAS THE ISSUE RESOLVED? PATIENT WILL NEED TO COME BACK FOR ANOTHER PROCEDURE, IF THE PROVIDER WANTS TO PROCEED AGAIN. WAS THERE A NEED TO REPEAT THE PROCEDURE? UNKNOWN AT THIS TIME. IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE FOR THE EVALUATION? NO.

  Patient problems: Insufficient Information

  MAUDE report 14373051 ↗
• MalfunctionDec 30, 2021Fluid/Blood Leak; Defective Device

  OUT OF THE BOX, THE MANOMETER AND VALVE JUNCTION ARE NOT SEALING ADEQUATELY. WE ALSO TRIED THE MANOMETER WITH A SEPARATE STOPCOCK AND THAT ALSO LEAKED. PHYSICIAN CONDUCTED TROUBLESHOOTING METHODS, ULTIMATELY DISCONNECTED FROM PATIENT AND TESTED EQUIPMENT WITH PF 0.9 NS (NORMAL SALINE). PER PHYSICIAN: "REASSESSED WITH THE MANOMETER, AND THERE WAS A LEAK AT THE JUNCTION OF THE MANOMETER AND THE STOPCOCK. EVEN AFTER PUSHING THE TWO TOGETHER WITH SIGNIFICANT PRESSURE, AND GREATER FORCE THAN I HAD EVER USED, IT STILL LEAKED AT THIS JUNCTION. AFTER SPINNING IT IN CIRCLES IN THE VALVE WITH LOTS OF PRESSURE, I WAS FINALLY ABLE TO GET IT INTO A POSITION THAT IT WOULDN'T LEAK." MANUFACTURER RESPONSE FOR LUMBAR PUNCTURE TRAY (ADULT PEDIATRIC), SAFE-T (PER SITE REPORTER). RESPONSE FROM MANUFACTURER: THE ROOT CAUSE, AS IS CURRENTLY DETERMINED, IS BASED ON IRREGULARITIES IN THE CONICAL SURFACE OF THE MATING AREA OF THE MANOMETER. IN ORDER TO ADDRESS THIS ISSUE, OUR MANUFACTURING TEAM HAS IMPLEMENTED AN UPDATE TO THE MANUFACTURING AND INSPECTION PLAN TO REQUIRE PRODUCT SAMPLING EVERY 30 MINUTES. WE ARE ALSO REQUIRING BLADE MAINTENANCE 1X PER MONTH AT MINIMUM, AND DEVELOPING NEW VISUAL STANDARDS T

  Patient problems: Insufficient Information

  MAUDE report 13117513 ↗
• InjuryNov 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MANOMETER SEEMS TO BE FAULTY AT THE INSERTION TO THE STOPCOCK (LEAKAGE). VERBATIM: AS INDICATED IN THE REPORT, LEAKAGE OCCURRED RELATED TO THE MANOMETER. I SPOKE WITH /OMITTED/, THE IMAGING CLINICAL PROGRAM COORDINATOR, WHO DESCRIBED WHAT SOUNDS LIKE A VISIBLE DEFECT ON THE MANOMETER WHERE IT CONNECTS TO THE STOPCOCK. SHE SAID THEY COMPARED UNUSED PRODUCT ¿ PEDIATRIC VERSION TO AN ADULT VERSION FROM THE SAME LOT NUMBER AS THE ITEM THAT LEAKED ¿ AND THE DIFFERENCE/DEFECT WAS VISIBLE. AS WE REACH OUT TO REPORT THE EVENT, WE WANT TO WORK WITH YOU TO DETERMINE HOW TO PROCEED WITH THIS PRODUCT (OR A REPLACEMENT PRODUCT) IN FUTURE CASES. PLEASE PROVIDE ANY INFORMATION REGARDING PREVIOUS EVENTS WITH THIS PRODUCT AND A PLAN TO WORK TOGETHER TO CONDUCT THE INVESTIGATION OF THE DEFECT/ADVERSE REACTION. PER EMAIL ATTACHMENT - "...IT APPEARS THAT OUT OF THE BOX THE MANOMETER AND VALVE JUNCTION IS NOT SEALING ADEQUATELY. WE ALSO TRIED THE MANOMETER WITH A SEPARATE STOPCOCK AND THAT ALSO LEAKED.... "WHAT STEPS WERE TAKEN TO DETERMINE IF THIS EVENT WAS CAUSED BY A USE ERROR? (E.G. REVIEWED INSTRUCTIONS FOR USE, CONFIRMED PROPER TRAINING ON DEVICE USAGE) - ATTENDING PHYSIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787079 ↗
• InjuryNov 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MANOMETER SEEMS TO BE FAULTY AT THE INSERTION TO THE STOPCOCK (LEAKAGE). VERBATIM: AS INDICATED IN THE REPORT, LEAKAGE OCCURRED RELATED TO THE MANOMETER. I SPOKE WITH /OMITTED/, THE IMAGING CLINICAL PROGRAM COORDINATOR, WHO DESCRIBED WHAT SOUNDS LIKE A VISIBLE DEFECT ON THE MANOMETER WHERE IT CONNECTS TO THE STOPCOCK. SHE SAID THEY COMPARED UNUSED PRODUCT ¿ PEDIATRIC VERSION TO AN ADULT VERSION FROM THE SAME LOT NUMBER AS THE ITEM THAT LEAKED ¿ AND THE DIFFERENCE/DEFECT WAS VISIBLE. AS WE REACH OUT TO REPORT THE EVENT, WE WANT TO WORK WITH YOU TO DETERMINE HOW TO PROCEED WITH THIS PRODUCT (OR A REPLACEMENT PRODUCT) IN FUTURE CASES. PLEASE PROVIDE ANY INFORMATION REGARDING PREVIOUS EVENTS WITH THIS PRODUCT AND A PLAN TO WORK TOGETHER TO CONDUCT THE INVESTIGATION OF THE DEFECT/ADVERSE REACTION. PER EMAIL ATTACHMENT - IT APPEARS THAT OUT OF THE BOX THE MANOMETER AND VALVE JUNCTION IS NOT SEALING ADEQUATELY. WE ALSO TRIED THE MANOMETER WITH A SEPARATE STOPCOCK AND THAT ALSO LEAKED. WHAT STEPS WERE TAKEN TO DETERMINE IF THIS EVENT WAS CAUSED BY A USE ERROR? (E.G. REVIEWED INSTRUCTIONS FOR USE, CONFIRMED PROPER TRAINING ON DEVICE USAGE) - ATTENDING PHYSICIAN COND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12759935 ↗
• InjuryMar 17, 2021Break; Fracture; Break; Fracture

  MATERIAL NO.: 4306CWSP BATCH NO.: 0001389762. IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE PATIENT'S BACK. PER ATTACHED COMPLAINT DETAILS: THE INQUIRER BELOW STATES THEY WERE USING A SPINAL TRAY AND THE NEEDLE BROKE OFF IN THE PATIENT¿S BACK. THEY WERE ABLE TO REMOVE THE NEEDLE USING X-RAY. THE PRODUCT IS ATTACHED AND I INFORMED THE INQUIRER TO HOLD ONTO THE NEEDLE REMNANTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11506028 ↗