Alaris, SmartSite 2205ERecalls & reported problems

BD Switzerland Sàrl · 20mm Vial Access Device, Needle-free Valve, 3.5 cm (1.5 in) · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613203011778), received between Nov 18, 2020 and Jan 13, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Contamination1
Leak/Splash1
Material Deformation1
Tear, Rip or Hole in Device Packaging1

Patient problems

No Clinical Signs, Symptoms or Conditions3
Chemical Exposure1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJan 13, 2026Tear, Rip or Hole in Device Packaging
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058129 ↗
MalfunctionJan 16, 2025Contamination; Contamination
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172664 ↗
MalfunctionAug 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED WHILE USING BD VIAL ACCESS DEVICE THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SALES REPORTED THAT: THE COMPANY'S PURCHASING FEEDBACK IS NOT UNPACKED FOUND PUNCTURE HEAD BENT NEEDLE SAMPLES CAN NOT RETURN, THERE ARE PHOTOS NO NEED TO CLAIM, NEED A COMPLAINT RESPONSE LETTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17452679 ↗
InjuryNov 18, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE VIAL ACCESS DEVICE EXPERIENCED DEFECTIVE/DAMAGED TUBING AND WAS INVOLVED WITH CHEMO EXPOSURE. THE CHEMOTHERAPY DRUGS DAMAGED THE SKIN MUCOSA, BUT DOES NOT SPECIFY WHETHER MEDICAL INTERVENTION/TREATMENT WAS APPLIED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS TREATED IN THE INTERVENTIONAL ONCOLOGY DEPARTMENT OF THEIR HOSPITAL BECAUSE OF NASAL CAVITY CANCER. AT 9:00 AM ON (B)(6) 2020, IN ORDER TO ENSURE THE PATIENT'S TREATMENT EFFECT, THE NURSE USED THIS INFUSION CONNECTOR TO PREPARE THE PATIENT WITH CHEMOTHERAPY DRUGS. SUDDENLY THE INFUSION CONNECTOR WAS BROKE AND COULD NOT CONTINUE, AND AT THAT TIME, THERE WAS AN OVERFLOW OF CHEMOTHERAPY DRUGS, WHICH HAD DAMAGE TO THE SKIN MUCOSA. IN ORDER TO PROTECT THE PATIENT¿S TREATMENT TIME AND EFFECT, THE NURSE HAD TO REPLACE THE INFUSION CONNECTOR AND RECONFIGURE THE MEDICINE TO ENSURE THAT THE PATIENT CAN BE TREATED NORMALLY, BUT THERE ARE BIG RISKS. IF THE NURSE DOES NOT RESPOND IN TIME, IT WILL INEVITABLY RESULT IN THE PATIENT NOT BEING TREATED ON TIME. IN ADDITION, CHEMOTHERAPY DRUGS ARE STRICTLY REGULATED. THEY ARE HARMFUL TO THE SKIN. THE NURSES ARE EQUIPPED WITH
Patient problems: Chemical Exposure
MAUDE report 10860351 ↗

Device details

UDI-DI	`07613203011778`
Brand	Alaris, SmartSite
Model	2205E
Company	BD Switzerland Sàrl
Product code	LHI · Set, i.V. Fluid transfer
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 31, 2025

Device type (GMDN): Intra-abdominal pressure measurement set, electronic

A collection of sterile devices intended to electronically measure intra-abdominal pressure (IAP) through the bladder. It typically includes an electronic pressure transducer, syringe, tubing, connectors, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), saline is infused into the bladder and IAP is measured by the transducer and displayed on, and powered by, a wire-connected monitor. It is typically used for patients at risk of intra-abdominal hypertension (IAH) e.g., following abdominal surgery/trauma. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

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All Set, i.V. Fluid transfer devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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