BD Insyte-W 381333Recalls & reported problems

Becton, Dickinson And Company · INSYTE-W WINGED PNK 20GA X 1.0IN · Class 2

All models of BD Insyte-W (8)

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

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00382903813339), received between Oct 27, 2022 and Jun 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (2 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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Device Damaged Prior to Use2
Material Perforation2
Device Contamination with Chemical or Other Material1

Patient problems

No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 12, 2026Material Perforation
IT WAS REPORTED BY CUSTOMER THAT STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. OBSERVED ISSUE PLEASE PROVIDE A DESCRIPTION OF THE OBSERVED ISSUE: STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. CUSTOMER RESPONSE ON 01-JUN-2026. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? - THIS HAS BEEN AN ONGOING ISSUE WITH THIS LOT NUMBER. DATE I HAVE PHOTOS FROM IS 05-21-2026 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. - COMPLICATION IS THE CATHETERS SEEM STICKY, WE CAN¿T ADVANCE THE CATHETER EASILY AND THE STYLET IS PIERCING THROUGH THE FLEXIBLE CATHETER 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? - I HAVE 2 FULL BOXES (100) PLUS AN OPEN BOX OF CATHETERS WITH THE SAME LOT NUMBERS THAT WE¿VE BEEN STRUGGLING WITH XXX".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488445 ↗
MalfunctionJun 12, 2026Material Perforation
IT WAS REPORTED BY CUSTOMER THAT STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. OBSERVED ISSUE: PLEASE PROVIDE A DESCRIPTION OF THE OBSERVED ISSUE: STYLETS ARE STICKY WHEN TRYING TO ADVANCE. ALSO HAVING A LOT OF THE NEEDLES POKING THROUGH THE CATHETER. CUSTOMER RESPONSE ON 01-JUN-2026. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? THIS HAS BEEN AN ONGOING ISSUE WITH THIS LOT NUMBER. DATE I HAVE PHOTOS FROM (B)(6) 2026. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. - COMPLICATION IS THE CATHETERS SEEM STICKY, WE CAN¿T ADVANCE THE CATHETER EASILY AND THE STYLET IS PIERCING THROUGH THE FLEXIBLE CATHETER. 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? - I HAVE 2 FULL BOXES (100) PLUS AN OPEN BOX OF CATHETERS WITH THE SAME LOT NUMBERS THAT WE¿VE BEEN STRUGGLING WITH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488441 ↗
MalfunctionAug 9, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BD INSYTE-W WINGED PNK 20GA X 1.0IN HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THEY CALLED INTO THE QUEUE AND STATED THERE WAS A CLEAR JELLY-LIKE SUBSTANCE COMING FROM THE TIP OF THE CATHETER (VERY SMALL AMOUNT AND STICKY). HAPPENED TWO TIMES. DID NOT USE ON PT. VERBATIM: CUSTOMER CALLED INTO THE QUEUE AND STATED THERE WAS A CLEAR JELLY-LIKE SUBSTANCE COMING FROM THE TIP OF THE CATHETER (VERY SMALL AMOUNT AND STICKY). HAPPENED TWO TIMES. DID NOT USE ON PT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19951024 ↗
MalfunctionOct 27, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BD INSYTE-W¿ IV CATHETER EXPERIENCED A DEFECTIVE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE HAD SEVERAL CATHETERS BLOW IN A ROW MAKING US CONCERNED THAT THIS BOX MAY BE DEFECTIVE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15678832 ↗
MalfunctionOct 27, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THE BD INSYTE-W¿ IV CATHETER EXPERIENCED A DEFECTIVE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAVE HAD SEVERAL CATHETERS BLOW IN A ROW MAKING US CONCERNED THAT THIS BOX MAY BE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15678830 ↗

Device details

UDI-DI	`00382903813339`
Brand	BD Insyte-W
Model	381333
Company	Becton, Dickinson And Company
Product code	FOZ · Catheter,intravascular,therapeutic,short-term less than 30 days
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 28, 2025

Device type (GMDN): Peripheral intravenous cannula

A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.

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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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