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) INTERVASCULAR CATHETER

Catalog Number 383328

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

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).

Event Description

It was reported that an unspecified number of bd saf-t-intima¿ safety system with removable prn 22 ga 0. 75 in (non-dehp) were involved with patients experiencing infection. Medical intervention was administered as a result. The following information was provided by the initial reporter: between august 2019 and now, 13 patients have been registered at the geriatrics unit in several different units for having presented inflammations (some of which were significant) at the puncture site of the subcutaneous device, sometimes associated with a local infectious problem, despite compliance with the institutional hygiene protocol in force (use of an alcoholic antiseptic on the skin before setting up the infusion, changing the device after a maximum of 96 hours) by personnel experienced in this type of procedure. For the other cases mentioned, as these were retrospectively reported cases, the batches were not listed at the time of the adverse event. Concerning the consequences on patients : 1 patient with hyperthermia due to infection at the subcutaneous infusion site (right thigh) with formation of a collection that required a blade incision and wicking. 1 patient who presented a collection of poor evolution at the sc puncture site on the abdomen: incision of the abscess that shows necrosis + antibiotic therapy + wicking. 1 patient with an abscess on the abdominal wall opposite the cs: antibiotic therapy + incision and drainage of the abscess + wicking. 1 patient with erythematous erythematous inflammatory oozing cupboard on the left flank: removal of the abscess roof for complete evacuation of the collection + antibiotic therapy + wicking.

• Brand Name: BD SAF-T-INTIMA SAFETY SYSTEM WITH REMOVABLE PRN 22 GA 0.75 IN (NON-DEHP)
• Type of Device: INTERVASCULAR 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: 10475304
• MDR Text Key: 210211434
• Report Number: 9610847-2020-00266
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 383328
• Device Lot Number: 0036796
• 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: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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: 08/31/2020 Patient Sequence Number: 1