MAUDE Adverse Event Report: BECTON DICKINSON US CATHENA 22GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386861
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 22gx1.00in straight bc - needle retraction failure verbatim: i wanted to bring to your attention that the 5th floor nursing encountered an issue where the needle did not retract properly.Fortunately, there was no harm caused to the patient.I have the needle in my office.Bd ref 386861 lot 5037663 expires 2028-01-31.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of needle retraction failure was confirmed upon inspection of the sample.Analysis of the sample showed the catheter adapter was missing.The safety mechanism was not activated and the tip shield was not detached from the grip/ needle hub.Damage was observed on the v-clip and the cannula was bent.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.The sample evaluation shows the tip shield positioned within the grip/needle hub.There is a possibility that the user may have mistakenly held the tip shield instead of the intended grip/needle hub, causing the catheter adapter to be forcibly detached from the tip shield.The failure was duplicated by holding the tip shield during retraction.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.

• Brand Name: US CATHENA 22GX1.00IN STRAIGHT BC
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22816269
• Report Number: 2243072-2025-01002
• Device Sequence Number: 21008492
• Product Code: FOZ
• UDI-Device Identifier: 00382903868612
• UDI-Public: (01)00382903868612(17)280131(10)5037663
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/16/2025

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: 5037663
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown