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 383313

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/31/2022

Event Type  malfunction  

Event Description

It was reported that foreign liquid was found in the bevel of the bd saf-t-intima¿ iv catheter safety system after removing it from the packaging.The following information was provided by the initial reporter, translated from portuguese: i remove an intima catheter 24 from the package, it has unidentified liquid in the bevel region, which made it impossible to use the catheter.

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

H6: investigation summary: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the photo.The photo showed no foreign matter.Dhr was reviewed and no qns or other events were found related to the complaint stated by the customer.

Event Description

It was reported that foreign liquid was found in the bevel of the bd saf-t-intima¿ iv catheter safety system after removing it from the packaging.The following information was provided by the initial reporter, translated from portuguese: "i remove an intima catheter 24 from the package, it has.Unidentified liquid in the bevel region, which made it impossible to use the catheter.".

• 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: 16261486
• MDR Text Key: 308548929
• Report Number: 9610847-2023-00008
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903833139
• UDI-Public: 00382903833139
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383313
• Device Lot Number: 1117631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/28/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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