MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383511
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 24 ga x 3/4 in single port catheter was defective and leaked it was reported by the customer that there was a hole in the catheter.Iv had to be removed from patient, and patient re-poked.Verbatim: rcc received a complaint via email.Email(s) attached.(b)(6) complaint reference #: (b)(4) hospital complaint reference #: (b)(4) correspondence language: english cat# of product being complained: (b)(4) description of product: catheter s-port 24gax0.75in nexiva 20ea/bx 4bx/ca lot or s/n: (b)(6) complaint category: damaged / broken incident date: (b)(6) 2025.Hospital complaint reference #: (b)(4) details of complaint (reported issue): "upon further inspection, rn noted that there was a hole in the catheter.Iv had to be removed from patient, and patient re-poked." additional information attached.Complaint noticed: during / after use problem frequency: 1st time customer exposure: patient injury: no has (b)(6) been informed? unknown qty affected: (b)(4) ea samples available? yes, is customer requesting an rga? no return qty: qty samples: (b)(4) ea iv inserted into patient, when rn withdrew the needle from the cannula, blood began pooling at the iv insertion site.Upon further inspection, rn noted that there was a hole in the catheter.Iv had to be removed from patient, and patient re-poked.
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
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.
Additional Manufacturer Narrative
Our quality engineer inspected the sample submitted for evaluation.The reported issue of catheter defective/ damaged was confirmed upon inspection of the sample.Analysis of the sample showed a punch mark on the catheter tubing.The sample was subjected to an air water leak test, and an air leak was observed at the punch mark.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 punch mark was successfully able to be recreated with another sample by puncturing the cannula halfway through the catheter tubing.The recreated punch mark had the same characteristic as the actual sample returned (y- shape mark).As mentioned in the product instructions for use (ifu), if the needle is partially or completely withdrawn from the catheter tubing, the needle should not be reinserted into the catheter tubing.

• Brand Name: BD NEXIVA 24 GA X 3/4 IN SINGLE PORT
• 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: 23840210
• Report Number: 2243072-2025-01506
• Device Sequence Number: 21214006
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)250413(17)280331(10)5100427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• 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,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 383511
• Device Lot Number: 5100427
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/20/2026; 02/10/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown