MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD ALCOHOL SWAB; PAD, ALCOHOL, DEVICE DISINFECTANT

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Date 01/03/2023

Event Type  malfunction  

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.

Event Description

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.

Event Description

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.

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.

• Brand Name: UNSPECIFIED BD ALCOHOL SWAB
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16274724
• MDR Text Key: 308524163
• Report Number: 2243072-2023-00101
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 59 KG