MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP) CATHETER

Catalog Number 383328

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Inflammation (1932)

Event Date 03/11/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Additional device lot #: 9057767; additional device expiration date: 2023-02-28. Additional device manufacture date: 2019-03-15.

Event Description

It was reported that bd saf-t-intima¿ safety system with removable prn 22 ga 0. 75 in (non-dehp). The following information was provided by the initial reporter: "over a period of 5-6 weeks, 3 patients developed severe inflammation at the puncture site (inflammation, induration, redness). One patient even had an abscess that had to be evacuated quickly. These catheters have been used for several years, the antisepsis protocol seems to have been respected, as well as the duration of insertion. Patient's current condition: excessive redness necessitated emergency surgical evacuation for one of the three patients. Actions taken: alcohol-based dressing for the 3 patients to reduce inflammation. Devices not kept. ".

• Brand Name: BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9907968
• MDR Text Key: 190979855
• Report Number: 9610847-2020-00116
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383328
• Device Lot Number: 9119696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/31/2020 Patient Sequence Number: 1