FDA Adverse Event Injury Summary report: N

STERIPACK STERILE POLYESTER SPUN SWAB

MDR report key: 16706672 · Received April 10, 2023

Report

Report Number: 3012642695-2023-00062
Event Type: Injury
Date Received: April 10, 2023
Date of Event: August 17, 2022
Report Date: April 10, 2023
Manufacturer: STERIPACK USA (LIMITED) LLC
Product Code: KXG
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

NOTE: LUMIRADX INC. PURCHASE STERIPACK STERILE POLYESTER SPUN SWABS FOR SALE/DISTRIBUTION TO CUSTOMERS FOR USE IN PATIENT SAMPLE COLLECTION, FOR TESTING WITH LUMIRADX PRODUCTS. LUMIRADX RECEIVED A REPORT FROM A CUSTOMER ON 17-AUG-2022, IDENTIFYING THAT WHEN USING A STERIPACK STERILE POLYESTER SPUN SWABS (SWAB LOT NUMBER 74933), FOR NASAL SAMPLE COLLECTION FROM A PATIENT (CHILD, 2 YEARS), THE SWAB BROKE IN THE PATIENT'S NOSE; THE STEM AT THE BASE OF THE APPLICATOR TIP SNAPPED OFF. PART OF THE SWAB WAS STUCK IN THE PATIENT'S NOSTRIL, WHICH WAS IMMEDIATELY AND SUCCESSFULLY REMOVED WITH TWEEZERS, BY A MEDICAL PROFESSIONAL. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED BY THE CUSTOMER TO LUMIRADX FOR THE REPORTED EVENT. EVENT DETAILS WERE REPORTED TO THE SWAB MANUFACTURER FOR INVESTIGATION. THE RECEIPT OF ANY NEW INFORMATION PERTAINING TO THIS EVENT WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

Description of Event or Problem · 0

THE CUSTOMER REPORTED THAT THE SWAB BROKE IN PATIENT'S NOSE WHILE SWABBING. PART OF THE SWAB WAS STUCK IN THE PATIENT'S NOSE, WHICH WAS SUCCESSFULLY REMOVED WITH TWEEZERS, BY A MEDICAL PROFESSIONAL. NO PATIENT HARM, INJURY OR ADVERSE HEALTH CONSEQUENCES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1730871	STERIPACK STERILE POLYESTER SPUN SWAB	STERIPACK STERILE POLYESTER SPUN SWAB	KXG	STERIPACK USA (LIMITED) LLC	60566	SWAB-74933, CARTON- 85430

Patients

Seq	Age	Sex	Outcome	Treatment
1	2 YR	Unknown