MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN; INTRAVASCULAR CATHETER

Model Number 383323

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 03/01/2022

Event Type  Injury  

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle safety mechanism didn't engage.This led to a dirty needlestick injury.The following information was provided by the initial reporter: it was reported needle retraction failure.(b)(6) 2022.A nurse was stuck with a contaminated needle after this happened when she was activating the safety and the needle came through and stuck her in the finger.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, 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: 19-apr-2022.Investigation summary: our quality engineer inspected the one sample and one photo submitted for evaluation.The reported issue of safety shield activation failure was not confirmed upon inspection of the sample.Bd determined that the cause of the failure was related to improper use of the device.The defect observed was most likely caused during activation of the device by the user pulling on the tubing.Doing so causes the tubing to stretch and then sling shot the needle into the tubing once released.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported while using bd saf-t-intima¿ safety system with y adapter 22 ga 0.75 in the needle safety mechanism didn't engage.This led to a dirty needlestick injury.The following information was provided by the initial reporter: it was reported needle retraction failure (b)(6) 2022.A nurse was stuck with a contaminated needle after this happened when she was activating the safety and the needle came through and stuck her in the finger.

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH Y ADAPTER 22 GA 0.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13848911
• MDR Text Key: 287619096
• Report Number: 9610847-2022-00112
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833239
• UDI-Public: 30382903833239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383323
• Device Catalogue Number: 383323
• Device Lot Number: 1243091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female