MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALCOHOL SWABS; ALCOHOL CLEANSING WIPE

Catalog Number 326910

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Swelling (2091); Chemical Exposure (2570)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an allergic reaction of swollen lips and tongue occurred after chemicals were inhaled from the box of bd alcohol swabs.It was also reported that the consumer claims to be allergic to certain types of cardboard.There was no report of medical intervention noted.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch #8051504.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no.

Event Description

It was reported that an allergic reaction of swollen lips and tongue occurred after chemicals were inhaled from the box of bd¿ alcohol swabs.It was also reported that the consumer claims to be allergic to certain types of cardboard.There was no report of medical intervention noted.

• Brand Name: BD¿ ALCOHOL SWABS
• Type of Device: ALCOHOL CLEANSING WIPE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7765019
• MDR Text Key: 116530295
• Report Number: 1920898-2018-00581
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 326910
• Device Lot Number: 8051504
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other