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

Catalog Number 383319

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Discomfort (2330)

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that the bd saf-t-intima¿ closed iv catheter system pulls out.The following information was provided by the initial reporter: ¿the stopper piece of the subcut line that the needle pulls out of is falling off the subcut lines.It is supposed to be tightly luer-locked on, but they are falling off, causing meds to leak and patients are missing meds as a result.This caused the patient to have increased pain.¿.

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: d10: device available for eval: yes.D10: returned to manufacturer on: 07-dec-2022.H6: investigation summary: our quality engineer inspected the 1 sample and 1 photo submitted for evaluation.The reported issues of cap loose and leakage were not confirmed upon inspection and testing of the sample.Analysis of the sample showed that the sample had no abnormalities or damages.During leakage testing the returned sample passed with no signs of leakage.The cause of the failure cannot be confirmed since the defect was not observed in the returned sample.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.

Event Description

It was reported that the bd saf-t-intima¿ closed iv catheter system pulls out.The following information was provided by the initial reporter: ¿the stopper piece of the subcut line that the needle pulls out of is falling off the subcut lines.It is supposed to be tightly luer-locked on, but they are falling off, causing meds to leak and patients are missing meds as a result.This caused the patient to have increased pain.¿.

• Brand Name: BD SAF-T-INTIMA¿ CLOSED IV CATHETER 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: 15929488
• MDR Text Key: 305925413
• Report Number: 9610847-2022-00457
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383319
• Device Lot Number: 1181313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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