MAUDE Adverse Event Report: BECTON DICKINSON CATHENA; INTRAVASCULAR CATHETER

Catalog Number	386861
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/27/2026
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 by the customer that when starting iv¿s yesterday ((b)(6) 2026) they encountered a failing safety device with both a 20g and 22g catheter from the lots referenced above.Additionally, as they didn¿t have other lot numbers in their inventory to pull from this morning ((b)(6) 2026), they encountered two of the 20g catheters (same lot # as above) in which the blood backflow preventer failed to work.In yesterday¿s safety device failure incidents, according to the endo team, one of their clinicians did suffer a needle stick with the 20g catheter.It appears we have 3 boxes (approx.150 each total) of the 20g catheter, all the same lot #, and 3 boxes (approx.150 each total) of the 22g catheter, again, all the same lot #, that we are pulling off the floor to prevent further usage.Verbatim: cathena 22ga and 20ga did not safety appropriately.One of the incidents caused an nsi hoping you can help us navigate this product issue, reporting, return, credit, etc.According to our xxxxteam, when starting iv¿s yesterday ((b)(6) apr2026) they encountered a failing safety device with both a 20g and 22g catheter from the lots referenced above.Additionally, as they didn¿t have other lot numbers in their inventory to pull from this morning ((b)(6) 2026), they encountered two of the 20g catheters (same lot # as above) in which the blood backflow preventer failed to work.In yesterday¿s safety device failure incidents, according to the endo team, one of their clinicians did suffer a needle stick with the 20g catheter.It appears we have 3 boxes (approx.150 each total) of the 20g catheter, all the same lot #, and 3 boxes (approx.150 each total) of the 22g catheter, again, all the same lot #, that we are pulling off the floor to prevent further usage.We need to have this matter reported accordingly especially in light of the injury to staff.Can you advise if this is a known issue or something isolated to this reporting? please advise next steps.".

• Brand Name: CATHENA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25162900
• Report Number: 2243072-2026-00372
• Device Sequence Number: 16136657
• Product Code: FOZ
• UDI-Device Identifier: 00382903868612
• UDI-Public: (01)00382903868612(10)5065222
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: 386861
• Device Lot Number: 5065222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown