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

Catalog Number 383318

Device Problems Leak/Splash (1354); Retraction Problem (1536)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system the needle would not retract properly resulting in leakage.The following information was provided by the initial reporter: the needle is exposed in manner it shouldn't be.When the catheter was fully inserted and needle removed the stopper didn't work and the needle came out exposed (and not in the safety part) since the stopper didn't work (fell off) blood proceeded to leak out of the catheter¿.

Event Description

It was reported that the bd saf-t-intima¿ iv catheter safety system the needle would not retract properly resulting in leakage.The following information was provided by the initial reporter: the needle is exposed in manner it shouldn't be.When the catheter was fully inserted and needle removed the stopper didn't work and the needle came out exposed (and not in the safety part) since the stopper didn't work (fell off) blood proceeded to leak out of the catheter¿.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of leakage at inserter/tubing was not confirmed but needle retraction failure was confirmed upon inspection of the photos.However, bd cannot confirm the causes of the failures to our manufacturing process since no sample was returned for evaluation.Review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.According to sampling plan applied for product performance, this lot was accepted.

• 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: 15183626
• MDR Text Key: 304899243
• Report Number: 9610847-2022-00292
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K013800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383318
• Device Lot Number: 1274909
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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