MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD ESWAB COLLECTION KIT, REGULAR; SYSTEM, TRANSPORT, ANAEROBIC

Catalog Number 220245

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that while using bd¿ eswab collection kit, regular a possible allergic reaction occurred.The patient eyes watered and had heavy feeling in head.Patient will have a follow up appointment with her physician.

Manufacturer Narrative

Investigation summary: the customer complaint on product 220245, lot 201217600, was not confirmed.No returns or photos were available.An investigation of the retains and device history record (dhr) did not indicate any issues that would contribute to the noted defect.A review of past complaints does not indicate a trend on this issue.Bd qa will continue to monitor for trending.

Event Description

It was reported that while using bd¿ eswab collection kit, regular a possible allergic reaction occurred.The patient eyes watered and had heavy feeling in head.Patient will have a follow up appointment with her physician.

• Brand Name: BD ESWAB COLLECTION KIT, REGULAR
• Type of Device: SYSTEM, TRANSPORT, ANAEROBIC
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 10843449
• MDR Text Key: 216352581
• Report Number: 1119779-2020-01006
• Device Sequence Number: 1
• Product Code: JTW
• Combination Product (y/n): N
• PMA/PMN Number: K061301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 220245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other