MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CULTURA; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number 00884450495834

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2020

Event Type  malfunction  

Event Description

The patient admitted to the ed with lower back pain radiating into bilateral upper legs.The patient has a history of chronic thoracic and lumbar pain and associated disc herniations, as well methamphetamine ivdu.Following work-up, plan was made to transfer for further evaluation of pain and determine if infectious etiology vs degenerative changes with radiculopathy.Prior to transfer, covid testing was ordered.Rn performed covid 19 nasopharyngeal swab in left nostril.The swab broke 4.5cm from red line where swab narrows.The pt immediately sniffed and swab disappeared into nare.The ed md was notified immediately.The pt blew his nose, with no return of the swab.A nasal speculum was used in attempt to locate and was unable to locate/visualize the swab.X-ray completed with no visualization.Ent was consulted and recommended afrin administration.Treatment initiated without retrieval of the swab.The patient demonstrated no respiratory distress - his only complaint was congestion.The patient was transferred for further evaluation of the low back pain, with plan for ent to evaluate patient.Nasal endoscopy was performed the following day after administration of lidocaine/phenylephrine for anesthesia and decongestion.The scope passed easily through both nares.On the left side, the nasal cavity is widely patent, the mucosa appears normal, and there is no sign of foreign body.Middle meatus and olfactory cleft examined and are normal.Identical findings on the right side.Nasopharynx appears without foreign body, minimal adenoid tissue.The patient later discharged home in stable condition.Manufacturer response for applicator, absorbent tipped, sterile, cultura¿ (per site reporter) no response - notified as fyi through product concerns process.

• Brand Name: CULTURA
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 10527436
• MDR Text Key: 206729436
• Report Number: 10527436
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 00884450495834
• UDI-Public: (01)00884450495834(17)210728(10)H1842077
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2020,09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450495834
• Device Catalogue Number: C100F/A
• Device Lot Number: H1842077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA
• Patient Weight: 77