MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 24GX0.75IN WINGED BC; INTRAVASCULAR CATHETER

Catalog Number	386815
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena 24gx0.75in winged bc safety shield activation failed it was reported by customer that when retracting the needle it was stuck to the cathelon.Attempting to remove it with required excessive force, dislodge the catheter, twice this occurred both with 24s.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): 40619 date of incident (yyyy-mm-dd): (b)(6) 2024 site name/location: bonnyville healthcare centre level of harm: no apparent harm - reached patient/person, inconvenient ahs optional report to cmdsnet (health canada): incident details: 24 gauge iv bd cathena ref (b)(4) when retracting the needle it was stuck to the cathelon.Attempting to remove it with required excessive force, dislodge the catheter, twice this occured both with 24s.Impact of incident: 2 successful iv insertions failed due to cathelon being dislodged when retracting the needle device information device name/description: catheter iv safety winged with multiguard 24gax0.75in cathena manufacturer: becton dickinson canada inc serial or lot number: unknown device expiry date (yyyy-mm-dd): unknown supplier: the stevens company ltd supplier catalogue number: 333-386815.

• Brand Name: BD CATHENA 24GX0.75IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19392381
• Report Number: 2243072-2024-00650
• Device Sequence Number: 12712632
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: (01)00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 386815
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown