MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 20GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386803
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
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 20gx1.00in straight bc catheter broke / separated before placement it was reported by the customer that pt was a very hard iv start, writer was able to get iv and then when i was unattaching the needle from the cathlon the white plastic plunger popped out of the cathlon end.When you attempt to attach the iv fluid tubing, nothing will flow.Therefore, the cathlon had to be removed as it would not work.Writer did not attempt to restart iv and left it for the anesthetist to do.Verbatim: rcc received a complaint via email.Incident or problem information.Ahs mdip reference number (id): (b)(4).Dates of incident (yyyy-mm-dd): (b)(6) 2025.Site name/location: (b)(6).Level of harm: hazard.Xxx optional report to cmdsnet (health canada): incident details: pt was a very hard iv start, writer was able to get iv and then when i was unattaching the needle from the cathlon the white plastic plunger popped out of the cathlon end.When you attempt to attach the iv fluid tubing, nothing will flow.Therefore, the cathlon had to be removed as it would not work.Writer did not attempt to restart iv and left it for the anesthetist to do.Device information device name/description: catheter iv safety non-winged with multiguard 20gax1.00in cathena manufacturer: xxxx manufacturer code/model: 386803 serial or lot number: (b)(6) device expiry date (yyyy-mm-dd): 2027-09-30 supplier: (b)(4) supplier catalogue number: 333-386803 was the device retained? no.Investigation request expected type of investigation: lot review clinical contact information manager (cc on final report): xxxxxx.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation.Therefore, the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD CATHENA 20GX1.00IN 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 NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22341140
• Report Number: 2243072-2025-00798
• Device Sequence Number: 21099798
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032(11)241002(17)270930(10)4265912
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 386803
• Device Lot Number: 4265912
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown