MAUDE Adverse Event Report: BD (SUZHOU) BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Leak/Splash (1354)

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

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: at 10:30 am on (b)(6) 2022, keep the leakage indwelling needle and report to the asset management department of the hospital.Adr# : (b)(4).

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 27-jun-2022.H6: investigation summary: a device history review was conducted for lot number 1350195.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, samples were submitted to aid in our investigation.Microscopic imaging of the returned device was allowed our engineers to identify a small breach in the extension tubing located at the connection point between the tubing and y-shaped housing.Based on location of the damage and the characteristics of the broken edge, our engineers have determined that the root cause for this event is related with manufacturing.Most likely the damage occurred as a direct result of variation in the flaring station, that results in an anomaly in the shaping of the metal wedge used to secure the extension tubing to the housing body.To address this issue our engineers have implemented increased the rate of quality inspection.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: at 10:30 am on (b)(6) 2022, keep the leakage indwelling needle and report to the asset management department of the hospital.Adr# (b)(6).

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15033998
• MDR Text Key: 304518399
• Report Number: 3014704491-2022-00281
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

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: Other
• Device Catalogue Number: 383033
• Device Lot Number: 1350195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1