MAUDE Adverse Event Report: BD SUZHOU (MDS) BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383336
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter pnk 20gax1.0in tubing defective damaged it was reported by customer that they noticed a hole in the flexible tubing after the iv was already in the patient, therefore leading to leakage during patient care.Verbatim: i wanted to bring to your attention a product issue we encountered with one of our 20gx 1.00 bd saf-t-intima safety system, with the y adapter.Ref# (b)(4)- premier item# 179246 which was used by one of our nursing staff on a patient yesterday on 4/7.The issue was the nurse noticed a hole in the flexible tubing after the iv was already in the patient, therefore leading to leakage during patient care.Additionally, i have the physical sample on hand and can send it safely and properly once the shipping label is received for further inspection.Please let me know if you have any questions or other information is needed.
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
Dhr review: the complaint lot#4298269, sku is 383336, assembly in suzhou plant1 on 2024.Nov.22, lot quantity is (b)(4).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: total 5 pictures provided, showing the product is after using, one of them shows small breach defect on tubing.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.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, hole is detected on tubing, 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 as conclusion: there are total 5 pictures attached, and one of them shows a small breach defect feature on extension tubing.We cannot identify which step causes the defect or it's a raw material defect.The retained sample appearance inspection and leakage test is performed, not defect detected, with this we cannot decide the root cause, only analyze possible reasons.
Event or Problem Description
No additional information available.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN
• 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: 21900943
• Report Number: 3006948883-2025-00099
• Device Sequence Number: 4059393
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: (01)00382903833368(11)241024(17)281031(10)4298269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/04/2025

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: 4298269
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown