MAUDE Adverse Event Report: BD SUZHOU (MDS) BD SAF-T-INTIMA W/PRN BL 22GA X .75IN; INTRAVASCULAR CATHETER

Catalog Number	383322
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
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/prn bl 22ga x.75in separation of adapter from tubing it was reported by customer that after placing the iv i took off all her labs and flushed her iv, then when it was about to disconnect the flush from the iv, the tubing broke off from the blue piece of the catheter.Verbatim: rcc received a complaint via email.Email(s) attached.No harm to patient.After placing the iv i took off all her labs and flushed her iv, then when i was about to disconnect the flush from the iv, the tubing broke off from the blue piece of the catheter.Product#: 383322.
Event or Problem Description
No additional information provided.
Additional Manufacturer Narrative
There is no batch#, both dhr review and retained sample review cannot be executed the reported information is the tubing broke off from the blue piece of the catheter.Highly possible a poor bonding issue between tubing and wing insertor.Possible reasons for such type of defect are: 1.Poor bonding performance due to less or no cyclohexanone during tubing/wing-inserter manual bonding process.2.Raw material defect from tubing or wing inserter the manufacture process have taken below actions to prevent or monitor above possible risk: 1.100% inspection was taken after bonding process, poor bonding status can be identified 2.Both in-process and out-going sampling will check the separation force between tubing and wing-inserter.There is no batch#, both dhr review and retained sample review cannot be executed, possible reason analysis only, we could not identify the root cause.

• Brand Name: BD SAF-T-INTIMA W/PRN BL 22GA X .75IN
• 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 (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21549196
• Report Number: 3002601200-2025-00105
• Device Sequence Number: 20874070
• Product Code: FOZ
• UDI-Device Identifier: 00382903833221
• UDI-Public: (01)00382903833221
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: 383322
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Female