MAUDE Adverse Event Report: QUEST PBS (PHOSPHATE BUFFERED SALINE) NP SWAB COVID- 19 NASAL SWAB TEST; APPLICATOR, ABSORBENT TIPPED, STERILE

Lot Number SWAB LOT#041520B01

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Medical provider was testing participant for covid-19 (using a quest pbs phosphate buffered saline np swab) that was placed in the nares.Before provider could spin swab, it broke in participant's nose.Provider was unable to remove it from posterior aspect of nose.It subsequently ended up in the pharynx where she swallowed it.She did not have any difficulty swallowing.Labone inc subsidiary of quest diagnostics, (b)(4).Us.Kit lot # i5mu4-04/14/2021.Fda safety report id# (b)(4).

• Brand Name: QUEST PBS (PHOSPHATE BUFFERED SALINE) NP SWAB COVID- 19 NASAL SWAB TEST
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• MDR Report Key: 10239079
• MDR Text Key: 197946245
• Report Number: MW5095376
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Lot Number: SWAB LOT#041520B01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR
• Patient Weight: 81