MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM; INTRAVASCULAR CATHETER

Model Number 383312

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 11/19/2021

Event Type  Injury  

Event Description

It was reported that the needle pierced through bd saf-t-intima¿ iv catheter safety system and delivered a dirty needle stick to the nurse.The patient was reported to be infected with (b)(6), and the nurse was reported to be (b)(6) pregnant.There was no further medical information provided.The following information was provided by the initial reporter, translated from chinese: "the head nurse reported that the extension tube was punctured by the needle during the puncturing process, resulting in needle injury of the injection nurse.The sales representative said: the injection nurse is pregnant with a (b)(6) baby, now it has a great impact".

Manufacturer Narrative

Investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.The photos provided clearly show the used device with the needle puncturing the tubing.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A potential cause of the failure could be improper activation of the device.If the device is pulled from the tubing to retract the needle, the tubing¿s elastic properties will cause the needle to be sling shot back into and through the catheter.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the needle pierced through bd saf-t-intima¿ iv catheter safety system and delivered a dirty needle stick to the nurse.The patient was reported to be infected with hiv and syphilis, and the nurse was reported to be 4-months pregnant.There was no further medical information provided.The following information was provided by the initial reporter, translated from chinese: "the head nurse reported that the extension tube was punctured by the needle during the puncturing process, resulting in needle injury of the injection nurse the patient was infected with hiv and syphilis the sales representative said: the injection nurse is pregnant with a 4-month baby, now it has a great impact".

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the 2 photos submitted for evaluation.The reported issue was confirmed upon inspection of the photos.The photos provided clearly show the used device with the needle puncturing the tubing.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A potential cause of the failure could be improper activation of the device.If the device is pulled from the tubing to retract the needle, the tubing¿s elastic properties will cause the needle to be sling shot back into and through the catheter.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.H3 other text : see h10.

• Brand Name: BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
• 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: 13048053
• MDR Text Key: 286109799
• Report Number: 9610847-2021-00602
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903833123
• UDI-Public: 30382903833123
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013800
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383312
• Device Catalogue Number: 383312
• Device Lot Number: 1082526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2021
• 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): Required Intervention