MAUDE Adverse Event Report: PROFESSIONAL DISPOSABLES INTERNATIONAL INC. PREVANTICS DEVICE SWAB; CHG 3.15% AND IPA 70% SWAB

Lot Number 11801707

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

Patient Problem Anaphylactoid (2218)

Event Date 02/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019 pdi was informed that a patient experienced an anaphylaxis reaction on (b)(6) 2019 shortly after her perma cath access hub was prepped for dialysis using the prevantics antiseptic device swab.According to the facility administrator, the patient's initial symptom was swelling, followed by the patient coding which required resuscitation for approx.8 minutes.Patient was intubated while in the icu.Providers did experience difficulty placing the intubation tube due to throat swelling.Patient spent a "couple" of days in the icu and was extubated prior to being moved to a step-down unit.Patient has been discharged from the hospital and is currently stable.Date of discharge is unknown.No changes in patient's care/condition since the anaphylaxis reaction, continues with dialysis 3x a week.Patient was noted as having skin allergy to chg on her medical chart prior to her dialysis treatment and use of this product.Unknown if she has any other allergies.Facility administrator added that patients with known chg allergies are prepped with alcohol prep pads only, and therefore the perma cath access hub should not be cleaned with chg products prior to dialysis treatment.Facility administrator advised that the prevantics product was used to clean the patient's hub during previous dialysis treatment.

• Brand Name: PREVANTICS DEVICE SWAB
• Type of Device: CHG 3.15% AND IPA 70% SWAB
• Manufacturer (Section D): PROFESSIONAL DISPOSABLES INTERNATIONAL INC.; two nice pak park; orangeburg NY 10962
• Manufacturer (Section G): PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.; two nice pak park; orangeburg NY 10962
• Manufacturer Contact: wendy gould ; two nice pak park; orangeburg, NY 10962 ; 8457925396
• MDR Report Key: 8497487
• MDR Text Key: 141432560
• Report Number: 2411192-2019-00001
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Lot Number: 11801707
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR