MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Break (1069)

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter the needle was broken.There was no report of patient impact.The following information was provided by the initial reporter: due to pressure ulceration at sacral tail and other areas, the patient was treated with closed venous indwelling needle for intravenous infusion at 9 o 'clock on (b)(6) 2022.The tip of venous indwelling needle was found to be broken, and the venous indwelling needle was replaced immediately, delaying the patient's treatment.

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

H.6.Investigation: a device history review was conducted for lot number 1111398.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter the needle was broken.There was no report of patient impact.The following information was provided by the initial reporter: due to pressure ulceration at sacral tail and other areas, the patient was treated with closed venous indwelling needle for intravenous infusion at 9 o 'clock on (b)(6) 2022.The tip of venous indwelling needle was found to be broken, and the venous indwelling needle was replaced immediately, delaying the patient's treatment.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14242251
• MDR Text Key: 290549251
• Report Number: 3014704491-2022-00163
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383033
• Device Lot Number: 1111398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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