MAUDE Adverse Event Report: BD SUZHOU (MDS) SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I; INTRAVASCULAR CATHETER

Catalog Number 383313

Device Problems Retraction Problem (1536); Material Protrusion/Extrusion (2979)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

"product fails with safety device, because at the end of the punch, when pulling the needle to activate the product's safety system, the water does not return completely, and when clamping to connect the serum, the needle is exposed, exposing the employee the risk of accident with drilling and sharp, a situation has already occurred in the sector.Product had never caused a problem before batch number 2287484, product purchased from industry itself, invoice (b)(4).Uninformed.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information provided.

Manufacturer Narrative

Dhr review: the complaint lot# is 2287484, sku is 383313, assembly in suzhou plant on 2022.Oct.29, 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: no samples returned, there are two pictures attached, it shows a product within unit package, show product manufacture information only but not the defect sample retain sample analysis: sampling 2ea from the retain sample of the same lot to check product function, product safety shield activation function is good.Refer to the attachment for retain sample test report.Possible cause analysis: based on the reported information, needle is exposure to air.Possible reasons for this type of failure may including: 1.The assembly status between outer shield and rubber is not good, the rubber is not pressed to the end during assembly 2.Product safety shield is pulled during manual assembly flow or manual packaging.Thess risk will cause the outer shield drops off before the needle retracted completely.Current manufacture already has control procedures as below to defect and prevent this kind of defect: 1.100% inspection for the gap between outer and rubber is performed at the last station of assembly 2.Both in-process and outgoing sampling check will test the separation force between rubber and outer shield there is no defect sample returned, also no defect sample picture provided, without this, we cannot identify the actual defect feature, cannot determine whether it¿s a poor assembly issue or raw material issue, so the root cause of this case is not clear.Based on the ifu description, hold the puller and keep the component adown can activate needle safety function successfully.

• Brand Name: SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I
• 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: 19011512
• MDR Text Key: 339012127
• Report Number: 3002601200-2024-00105
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: (01)00382903833139
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• 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: 383313
• Device Lot Number: 2287484
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• 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: 10/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1