MAUDE Adverse Event Report: BD SUZHOU (MDS) BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN; INTRAVASCULAR CATHETER

Catalog Number 383319

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

Bd saf-t-intima y adp yel 24ga x 0.75in row stylet damaged / defective.

Event Description

It was reported that bd saf-t-intima y adp yel 24ga x 0.75in stylet damaged / defective the following information was provided by the initial reporter: it was reported by customer that the insertion wire became dislodged from the safety mechanism.Verbatim: rcc received a complaint via chat.Pir attached.Issue: i was using a bd saf-t intima, and the insertion wire became dislodged from the safety mechanism pt harm - no staff harm - no - but risk of sample: no pictures yes date: (b)(6) 2024.

Manufacturer Narrative

Dhr review: the complaint lot# is 3048128, sku is 383319, assembly in suzhou plant on 2023.Mar.29, lot quantity is 38466ea review the in process test record and outgoing test report for above two lots, 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analysis: no sample returned, and there is one picture to show the defect sample which stylet/needle component has been withdrawn out from the inner sheath retain sample analysis: sampling 2ea from the each retain sample of the same lot to check assembly status for each component, and do safety function test, all test results are within product specification.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, stylet/needle component is pulled out from the inner sheath, possible reasons for this type of failure is: the size of the end hole of the molding parts inner sheath is abnormal, stylet/needle component pull out force is out of specification current manufacture already has control procedures as below to detect and prevent this kind of defect: 1.Qc sampling in-process check will test pull out force test for this feature during assembly.2.Finish goods measurement will check this pull force with these information we cannot identify the actual defect feature, the retain sample check results are all within product specifications, so we cannot identify the root cause for this case.

Event Description

No a needle stick did not occur.It was a near miss ¿ the safety became dislodged after it was inserted into the patient.Had the nurse not noticed that something was wrong, she could indeed have received a needle stick.Fortunately, she did not.

• Brand Name: BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN
• Type of Device: 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: 19016558
• MDR Text Key: 339127497
• Report Number: 3002601200-2024-00113
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833191
• UDI-Public: (01)00382903833191
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 383319
• Device Lot Number: 3048128
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1