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

Catalog Number 383313

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported that bd saf-t-intima w/y adapter yel 24ga x.75i safety shield activation failed and resulted in a needlestick in our institution there was an accident at work involving a nursing employee due to a quality deviation in the no.24 intravenous catheter.The employee reported that, after the venous access procedure, he left the material on the tray for disposal and when he discarded it, his hand was injured.After analyzing the product, it was found that the device protecting the material had not been activated correctly and one end of the probe remained sticking out.Our care practices department was called in and it was confirmed that the procedure carried out by our employee was correct and there was no fault in the technique.Here are the batches used, both the one involved in the accident and the test carried out afterwards: lots: 2319073 / 3167176 the samples were discarded due to contamination.Add info - apr 04 2024 - is there any impact on the patient/health professional other than the hand injury? no, only the puncture wound to the hand.- date of occurrence of the event: 01/04/2024.- sample photos are not available.

Manufacturer Narrative

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

Manufacturer Narrative

Dhr review: the complaint lot# 2319073 was assembled in suzhou plant on 2022.Nov.29, lot quantity is (b)(4) ea, lot#3167176 was assembled in suzhou plant on 2023.Jun.25, lot quantity is (b)(4) ea review the in process test record and outgoing test report for these two lots, all test results meet the product specifications, no abnormal found.Review the product assembly records, no non-conformities, deviations or rework activities returned sample analysis: no samples returned, one picture attached to show the unit label of manufacture information only, not show the sample.Retain sample analysis: sampling (b)(4) ea from the retain sample of two lots 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.

Event Description

No additional information provided.

• Brand Name: BD 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: 19204412
• MDR Text Key: 341301829
• Report Number: 3002601200-2024-00156
• Device Sequence Number: 1
• Product Code: FOZ
• 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,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383313
• Device Lot Number: 2319073
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention