UNSPECIFIED BD ALCOHOL SWAB

Description of Event or Problem

IT WAS REPORTED THAT THE UNSPECIFIED BD ALCOHOL SWAB EXPERIENCED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM GETS INFECTIONS AT HER REMODULIN IV CENTRAL LINE CATHETER SITE DUE TO THE ALCOHOL PREP PADS [CATHETER SITE INFECTION] CASE DESCRIPTION: CO-SUSPECT MEDICATION INCLUDED: ESTROGEN (ESTRADIOL). CONCOMITANT MEDICATIONS INCLUDED: SILDENAFIL CITRATE, OPSUMIT (MACITENTAN), AND XARELTO (RIVAROXABAN). RELEVANT MEDICAL HISTORY INCLUDED: PRIMARY PULMONARY ARTERIAL HYPERTENSION. IT WAS REPORTED THAT THE PATIENT HAD HER ANNUAL OBSTETRICIAN-GYNECOLOGIST APPOINTMENT AND WAS ADVISED THAT SHE WAS MENOPAUSAL. CO-SUSPECT MEDICATION INCLUDED ALCOHOL PREP PADS/ SWABS (ETHANOL). THE PATIENT REPORTED THAT SHE GETS INFECTIONS AT HER IV REMODULIN CENTRAL LINE CATHETER SITE DUE TO THE ALCOHOL PREP PADS (CATHETER SITE INFECTION). FURTHER STATED THAT THERE WAS NOT ENOUGH ALCOHOL IN THEM TO PROPERLY CLEAN THE SITE AND SHE GETS INFECTIONS FROM THIS. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENT OF CATHETER SITE INFECTION. AT THE TIME OF REPORTING, THE OUTCOME OF CATHETER SITE INFECTION WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENT OF CATHETER SITE INFECTION. THE REPORTER'S CAUSALITY FOR THE EVENT OF CATHETER SITE INFECTION WITH ALCOHOL PREP PADS WAS CONSIDERED TO BE POSSIBLY RELATED.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY NO SAMPLES INCLUDING PHOTOS WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED.

Additional 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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 03-JAN-2023. MEDWATCH REPORT # UNT-2022-031756.

Description of Event or Problem

IT WAS REPORTED THAT THE UNSPECIFIED BD ALCOHOL SWAB EXPERIENCED ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM GETS INFECTIONS AT HER REMODULIN IV CENTRAL LINE CATHETER SITE DUE TO THE ALCOHOL PREP PADS [CATHETER SITE INFECTION] CASE DESCRIPTION: CO-SUSPECT MEDICATION INCLUDED: ESTROGEN (ESTRADIOL). CONCOMITANT MEDICATIONS INCLUDED: SILDENAFIL CITRATE, OPSUMIT (MACITENTAN), AND XARELTO (RIVAROXABAN). RELEVANT MEDICAL HISTORY INCLUDED: PRIMARY PULMONARY ARTERIAL HYPERTENSION. IT WAS REPORTED THAT THE PATIENT HAD HER ANNUAL OBSTETRICIAN-GYNECOLOGIST APPOINTMENT AND WAS ADVISED THAT SHE WAS MENOPAUSAL. CO-SUSPECT MEDICATION INCLUDED ALCOHOL PREP PADS/ SWABS (ETHANOL). THE PATIENT REPORTED THAT SHE GETS INFECTIONS AT HER IV REMODULIN CENTRAL LINE CATHETER SITE DUE TO THE ALCOHOL PREP PADS (CATHETER SITE INFECTION). FURTHER STATED THAT THERE WAS NOT ENOUGH ALCOHOL IN THEM TO PROPERLY CLEAN THE SITE AND SHE GETS INFECTIONS FROM THIS. ACTION TAKEN WITH IV REMODULIN WAS NOT REPORTED FOR THE EVENT OF CATHETER SITE INFECTION. AT THE TIME OF REPORTING, THE OUTCOME OF CATHETER SITE INFECTION WAS UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY FOR THE EVENT OF CATHETER SITE INFECTION. THE REPORTER'S CAUSALITY FOR THE EVENT OF CATHETER SITE INFECTION WITH ALCOHOL PREP PADS WAS CONSIDERED TO BE POSSIBLY RELATED.