MAUDE Adverse Event Report: FOSUN PHARMA USA INC. NASOPHARYNGEAL SWAB

Device Problems Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This literature case, derived from an abstract, was received on (b)(6) 2023.It described a patient of unknown age and gender who had an "unusual retained choanal foreign body" (pt: foreign body in respiratory tract) post nasopharyngeal swab test for covid-19.Case report: this reports a case of a noncooperative patient in whom a complication occurred during a nasopharyngeal swab collection, where the plastic shaft of the swab fractured during the procedure, resulting in swab tip retention deep into the nasal cavity.The foreign body was found endoscopically, stuck between the nasal septum and the superior turbinate tail at the upper level of the left choana and removed under general anesthesia in a negative pressure operating room with the health care personnel wearing personal protective equipment.Author's comment: unpleasant complications like the one described can happen when the swab is collected without the necessary knowledge of nasal anatomy or conducted inappropriately, especially in noncooperative patients.Moreover, the design of currently used viral swabs may expose to accidental rupture, with risk of foreign body retention in the nasal cavities.In such cases, diagnosis and treatment are endoscopy-guided procedures performed in an adequate setting to minimize the risk of spreading of the pandemic.Literature citation: gaffuri m, capaccio p, torretta s, daga m, zuccotti gv, pignataro l.An unusual retained choanal foreign body: a possible complication of covid-19 testing with nasopharyngeal swab.Ear nose throat j.2023 mar;102(3):np136-9.Company comment: a patient had an unusual retained choanal foreign body (foreign body in respiratory tract) post nasopharyngeal swab test for covid-19.In response to the event, the patient underwent endoscopic surgical intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of foreign body in respiratory tract is assessed as possible with nasopharyngeal swab.The case is considered serious as surgical intervention was required.Foreign body in the respiratory tract are unlisted as per uspi.

Event Description

This literature case, derived from an abstract, was received on 26-apr-2023.It described a patient of unknown age and gender who had an "unusual retained choanal foreign body" (pt: foreign body in respiratory tract) post nasopharyngeal swab test for covid-19.Case report: this reports a case of a noncooperative patient in whom a complication occurred during a nasopharyngeal swab collection, where the plastic shaft of the swab fractured during the procedure, resulting in swab tip retention deep into the nasal cavity.The foreign body was found endoscopically, stuck between the nasal septum and the superior turbinate tail at the upper level of the left choana and removed under general anesthesia in a negative pressure operating room with the health care personnel wearing personal protective equipment.Author's comment: unpleasant complications like the one described can happen when the swab is collected without the necessary knowledge of nasal anatomy or conducted inappropriately, especially in noncooperative patients.Moreover, the design of currently used viral swabs may expose to accidental rupture, with risk of foreign body retention in the nasal cavities.In such cases, diagnosis and treatment are endoscopy-guided procedures performed in an adequate setting to minimize the risk of spreading of the pandemic.Literature citation: gaffuri m, capaccio p, torretta s, daga m, zuccotti gv, pignataro l.An unusual retained choanal foreign body: a possible complication of covid-19 testing with nasopharyngeal swab.Ear nose throat j.2023 mar;102(3):np136-9.Company comment: a patient had an unusual retained choanal foreign body (foreign body in respiratory tract) post nasopharyngeal swab test for covid-19.In response to the event, the patient underwent endoscopic surgical intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of foreign body in respiratory tract is assessed as possible with nasopharyngeal swab.The case is considered serious as surgical intervention was required.Foreign body in the respiratory tract are unlisted as per uspi.Additional significant information was received on 05-may-2023 from a full-text article.Patient demographics (age and gender) was added to the case.Case report: a 37-year-old noncompliant male with down syndrome presented to the emergency department (ed) after an attempt of covid-19 testing at his day care facility performed because of a close contact with a confirmed case.During the procedure, a sudden head movement led to the engagement of swab tip break point mechanism while the nasopharyngeal swab (nps) was still in the left nasal cavity resulting in swab tip retention deep into the nasal cavity, completely out of direct vision.A second nps for covid-19 testing was collected at the ed (with nps inserted through the right nasal cavity), and a head lateral plain radiograph with no evidence of retained foreign body; a subsequent bedside otorhinolaryngological examination by means of a single-use flexible 3-mm endoscope (ambu ascope 4 rhinolaryngo slim device) and a high-definition (hd) monitor (ambu aview) showed the tip of the swab retained in the left nasal cavity, stuck between the nasal septum (ns) and the superior turbinate tail at the upper level of the left choana.The foreign body location could not be easily reached, because of a severe deviation of the ns and a concomitant hypertrophy of the inferior and middle turbinate.As the nps performed at the ed resulted positive to covid-19, the patient was transferred to a covid-19 ward, and an operating room (or) equipped for the management of covid-19 patients was set up.Due to the deep location of the foreign body and narrow nasal cavity due to the concomitant septal deviation, the risk of displacement during removal maneuver and the noncompliant attitude of the patient, the procedure was performed in a negative pressure or, with all the health care personnel wearing personal protective equipment, under general anesthesia with laryngeal mask.After topical vasoconstriction of the nasal mucosa with xylometazoline hydrochloride, the foreign body was removed by means of a single-use 5-mm flexible bronchoscope (ascope 4 broncho regular), a hd monitor (ambu aview) and flexible endoscopy forceps inserted through the 2.2-mm operative channel of the bronchoscope.The tip of the nasal swab was grasped using flexible endoscopy forceps and retrieved from the left nasal cavity; the plastic shaft was hidden in the superior meatus and angled with an upper concavity, with no chance of detection during the diagnostic flexible video endoscopy.No further foreign bodies were detected in the nasal cavities.The patient was kept under observation for a few hours without occurrence of nasal bleeding or any other complication and then referred to a covid-19 ward.Author's comment: testing for covid-19 can lead to unpleasant complications when nps is performed without the necessary knowledge of nasal anatomy and when conducted inappropriately, especially in noncooperative patients.In this case, the nasopharynx was very difficult to be accessed through the left nasal cavity due to a severe septal deviation, extending from the inferior to the middle meatus, and a concomitant hypertrophy of the inferior and middle turbinate; quite the opposite, the right nasal cavity was patent and free from any anatomical obstruction.The hypothetical dynamics of this complication can be summarized as: the nps, introduced in the left nasal cavity, was pushed high up in the nasal cavity because of the impossibility to pass through the inferior meatus, and forced against the choanal wall, it broke in 2 parts and folded up, and was subsequently embedded in the superior meatus at the upper level of the choana.The painful nps insertion in this narrow nasal cavity exacerbated the already noncooperative attitude of the patient.In such a case, a better familiarity with anterior rhinoscopy could lead to the choice of the more accessible nasal cavity to make the sampling procedure less discomfortable.Literature citation: gaffuri m, capaccio p, torretta s, daga m, zuccotti gv, pignataro l.An unusual retained choanal foreign body: a possible complication of covid-19 testing with nasopharyngeal swab.Ear nose throat j.2023 mar;102(3):np136-9.Company comment: a patient had an unusual retained choanal foreign body (foreign body in respiratory tract) post nasopharyngeal swab test for covid-19.In response to the event, the patient underwent endoscopic surgical intervention.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of foreign body in respiratory tract is assessed as possible with nasopharyngeal swab.The case is considered serious as surgical intervention was required.Foreign body in the respiratory tract are unlisted as per uspi.

• Brand Name: NASOPHARYNGEAL SWAB
• Type of Device: NASOPHARYNGEAL SWAB
• Manufacturer (Section D): FOSUN PHARMA USA INC.; suite 204; 104 camegie center; princeton NJ 08540
• Manufacturer Contact: kathy zhang ; suite 204; 104 camegie center; princeton, NJ 08540
• MDR Report Key: 16901109
• MDR Text Key: 314887596
• Report Number: 3015145560-2023-00004
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male