MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383323
Medical Device Problem Codes	Material Puncture/Hole (1504); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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.B3.The date received by manufacturer has been used for this field as the date of the event is unknown.
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter bl 22ga x.75in -catheter defective / damaged.Verbatim: rcc received a complaint via email.Email(s) attached.Started 22 gauge iv on patient for labs and treatment.When removing the guidewire iv started leaking.Upon inspection there was a hole in the tubing.Product#: 383323.Lot#: 4171437.
Additional Manufacturer Narrative
Dhr review: the complaint lot 4171437, sku is 383323, assembly in suzhou plant 1 on 2024.Jul.5, lot quantity is (b)(4) ea.Review the in-process test record and outgoing test report, all test results meet the product specifications, no abnormal found.Review the product assembly record, no non-conformities, deviations or rework activities for this lot.Return sample analysis: no pictures provided to show defect feature.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check catheter status and tubing status, no defect detected, leakage test result is within specification as well.Possible cause analysis: based on the reported information, damage is detected on catheter and cause a leakage, the possible reason is as below: 1.The raw material has defect.2.Component damage happened during assembly.Current manufacture process has taken control procedures as below to protect this kind of possible risk: 1.100% common inspection is performed during each process station start from tubing bonding process.2.Common inspection is performed during packaging process.3.Qc sampling check will inspect the component appearance and do leakage test.Conclusion(s): we cannot identify which step causes the damage or it's a raw material defect.The retained sample appearance inspection and leakage test is performed, no defect detected.With this we cannot decide the root cause.
Event or Problem Description
No additional information is available.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22829859
• Report Number: 3006948883-2025-00492
• Device Sequence Number: 18522309
• Product Code: FOZ
• UDI-Device Identifier: 00382903833238
• UDI-Public: (01)00382903833238(17)280630(10)4171437
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• 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
• Report Date (Section B): 08/30/2025

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: 383323
• Device Lot Number: 4171437
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 08/30/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown