MAUDE Adverse Event Report: BECTON DICKINSON SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	383313
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 saf-t-intima w/y adapter yel 24ga x.75i - catheter defective / damaged productcomplaint - customer called to report that they have experienced leakage using the saf-intima, a couple of times there has been instances where the tubing after being clamped has a perforation leading to leakage of blood and medication.Doe - ongoing, unused samples available, no pt harm reported.Ref 383313, lot 1227303.
Event or Problem Description
No additional information is available.
Additional Manufacturer Narrative
Dhr review: the complaint lot#1227303, sku is (b)(4), assembly in suzhou plant1 on 2021.Oct.09, a planned quantity of this lot is 24000ea.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 showing defect feature.No samples returned.Retain sample analysis: sampling 2ea from the retain sample of the same lot to check product appearance, no defect detected, leakage test result is within specification as well.Possible cause analysis: based on the reported information, damage is detected on tubing 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: 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, only analyze possible reasons.

• Brand Name: SAF-T-INTIMA
• 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: 22796208
• Report Number: 3006948883-2025-00467
• Device Sequence Number: 18208911
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139(17)250930(10)1227303
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 383313
• Device Lot Number: 1227303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown