MAUDE Adverse Event Report: BD SUZHOU (MDS) SAF-T-INTIMA; INTRAVASCULAR CATHETER

Catalog Number	383336
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
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 pnk 20gax1.0in leaked it was reported by customer that 20 gauge iv placed in r forearm.Good blood return noted.Wire removed.Blood noted on tubing.When flushed, blood and saline leaked from tubing.Iv insertion site intact.Iv pulled out.Tubing appeared to leak just above butterfly wings.Verbatim: rcc received a complaint via email.I¿m reaching out regarding a safety incident that involved bd item # 383336 (saf-t-intima integrated catheter system with y adapter, pink, 20g x 1").Please see noteworthy event details below: 1.Description: 20 gauge iv placed in r forearm.Good blood return noted.Wire removed.Blood noted on tubing.When flushed, blood and saline leaked from tubing.Iv insertion site intact.Iv pulled out.Tubing appeared to leak just above butterfly wings.Package saved.2.The event occurred on 5/31/2025.3.The lot number was 4145188.4.The defective item was not saved and cannot be sent for further assessment.5.Harm level: no harm to patient or clinical staff.
Event or Problem Description
No additional information available.
Additional Manufacturer Narrative
Dhr review: the complaint lot# is 4145188, sku is 383336, assembly in suzhou plant on 2024.Jun.17, 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.Returned sample analysis: based on customer report defective item was not saved and cannot be sent.Retain sample analysis: sampling 2ea from the retain sample of the same lot to do leakage test, test result is within product specification.Refer to the attachment for retain sample test report.Possible cause analysis: based on the information, leakage is reported from tubing.The possible reasons for this type of failure may including: 1.Tubing damage/broken issue, or poor prn assembly status.2.The swaging between tubing and luer-adapter is not good, leakage is from the swaging location.3.Extension tubing bonding performance is poor.Current manufacture already has control procedures as below to monitor and prevent this kind of defect: 1.Both in-process and outgoing sampling will check the pull force related extension tubing and the component at its both ends, including the swaging force and bonding force, a poor connection can be detected.2.Both in-process and outgoing sampling check do leakage test for component with extension tubing and prn connector.Defective sample was not saved and cannot be sent, the retain sample leakage test result is pass, so the root cause is not clear for this leakage issue.

• Brand Name: SAF-T-INTIMA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22522355
• Report Number: 3006948883-2025-00299
• Device Sequence Number: 13069222
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: (01)00382903833368(17)280531(10)4145188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: 383336
• Device Lot Number: 4145188
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown