BD PhaSeal Optima 515629Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00382905156298), received between Oct 30, 2025 and Sep 30, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Disconnection” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Disconnection

  The following information was provided by the intiial reporter:It was reported that the connection between the injector and the spike port came loose. User reconnected it and continued using the unit as is.Additional Information was received on 15 Sep 2026:Additional information: The information acquisition date was entered incorrectly; the correct date of obtaining information is 9 14. The event occurrence date is 9 8.Follow up performed to verify:What lot was used in this event?Is the facility new to using OptimaHas education been provided on connection techniques.Rep mentioned that:UnknownImplementation began at the end of August. It hasn¿t even been a month yet.A training session has already been held.Additional information provided:A leak has been confirmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946161 ↗
• MalfunctionSep 23, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876323 ↗
• MalfunctionSep 22, 2026Disconnection; Leak/Splash

  No additional information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862364 ↗
• MalfunctionSep 18, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831240 ↗
• MalfunctionSep 18, 2026Infusion or Flow Problem

  The following information was provided by the initial reporter:According to the customer report, an incident occurred where air entered in the IV line during chemotherapy use. The product was recalled.Since air was detected in the IV line during administration, the IV connection line was exchanged. (Small container)Air entered the IV line again during administration using the new IV connection line.Although we reported the possibility that air had entered from the JMS spike with an air vent, we were asked to investigate, so we recalled the product.Contaminated with It is the route through which the anticancer drug is administered.Additional information received on 07 Sep 2026.Thank you for contacting us.Did this occur in the primary line or the secondary line? It occurred in the primary line.Did this occur while an infusion pump was in use? It likely occurred while the pump was in use.Is the IV administration set manufactured by BD? It is manufactured by JMS.Was the IV administration set vented? Unknown.If it was vented, was the vent inlet closed? Was the IV administration set primed before the infusion started?Yes, it was primed.How much time had passed since the infusion started

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828908 ↗
• MalfunctionAug 25, 2026Disconnection; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442690 ↗
• MalfunctionAug 25, 2026Disconnection; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442041 ↗
• MalfunctionAug 25, 2026Disconnection; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50442040 ↗
• MalfunctionAug 12, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222190 ↗
• MalfunctionAug 11, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50216850 ↗
• MalfunctionDec 23, 2025Leak/Splash; Separation Problem; Leak/Splash; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23884024 ↗
• MalfunctionOct 30, 2025Leak/Splash; Leak/Splash

  EVENT DETAILS: THIS IS A COMPLAINT ABOUT FLUID LEAKED OUT FROM THE INFUSION BAG FITTED WITH THE OPTIMA SPIKE. IV LINE CONNECTION KIT USED IN COMBINATION WITH THE SPIKE. WHILE ADMINISTERING INFUSION BY ATTACHING THE OPTIMA SPIKE TO THE INFUSION BAG AND CONNECTING IT TO THE OPTIMA IV LINE CONNECTION KIT, THE FLUID LEAKED OUT OF THE INFUSION BAG AND TRANSMITTED TO THE INFUSION SET. THE ACTUAL PRODUCT IS STILL IN USE BY A PATIENT AND IS SCHEDULED FOR RECALL AT A LATER DATE. CAN WE CONFIRM WITH THE CUSTOMER, WAS THE LEAK BETWEEN THE SPIKE OF THE CONNECTOR AND THE IV BAG? UNKNOWN: THE LEAK WAS DISCOVERED WHEN 515629 WAS CONNECTED TO 515628, AND ANTICANCER DRUGS WERE TRANSFERRED TO THE HOSPITAL INFUSION SET CONNECTED TO 515629. ANTICANCER DRUG CONTAMINATION. THE HOSPITAL DID NOT CONFIRM THE LOCATION OF THE LEAK. WHAT BRAND IV BAG WAS BEING USED? OTSUKA PHARMACEUTICAL GLUCOSE 500ML. WAS THE SPIKE FULLY INSERTED WHEN THE LEAK WAS OBSERVED? INSERTED. WAS THERE ANY PATIENT OR USER IMPACT? YES. IF YES, PLEASE DESCRIBE: PATIENT TREATMENT DELAYED (THE PLANNED AMOUNT MAY HAVE NOT BEEN ADMINISTERED. THE AMOUNT OF LEAKAGE WAS CONFIRMED; IT WAS DETERMINED TO BE MINIMAL AND NOT A PROBLEM FOR TREATMEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424477 ↗
• MalfunctionOct 30, 2025Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423902 ↗