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U.S. Department of Health and Human Services

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

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FOSUN PHARMA USA INC. NASOPHARYNGEAL SWAB Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Respiratory Failure (2484); Epistaxis (4458)
Event Type  Injury  
Event Description
This case, derived from the full-text scientific literature study article, titled "nasopharyngeal swabs in pediatric patients with thrombocytopenia and anticoagulant use," was received on (b)(6) 2023.Study aim: the aim of this study was to explore pediatric hematology/oncology (pho) specialists' opinions, experiences, and institutional practices of nasopharyngeal (np) swab testing in pediatric patients with thrombocytopenia and/or anticoagulant use.In addition, it was examined whether individuals and institutions considered non-np sources of nucleic acid amplification tests (naats) for covid-19-specific diagnosis in pho patients perceived to be at high risk of np swab complications.Methods: the mayo clinic institutional review board approved this study.A multidisciplinary team consisting of a pho specialist, pediatric infectious disease specialist, pediatric emergency medicine specialist, and pediatric residents, with interests in covid-19 testing devised the survey questions and instrument.Three researchers created initial survey questions together.Two independent researchers who were blind to the writing of the survey questions took a practice sample of the survey and helped revise the initial survey.The survey questions were inclusive of all types of adverse events.The survey was constructed in the electronic data tool redcap."adverse event" was defined according to the institute for healthcare improvement: "unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization, or that results in death".There was no identifying data collected except an optional section where respondents could report their institution.Student t test was used for comparative analysis.The survey was emailed to all (b)(4) active pho physicians who were part of the children's oncology group in (b)(6) 2022.Respondents were allowed 4 weeks to respond and were sent 1 email reminder.Descriptive statistical analysis, including median, mean, and interquartile ranges (iqrs), were calculated in redcap and duplicated in microsoft excel.Two independent researchers performed statistical analysis of platelet cutoff levels and had 100 percent inter researcher agreement.Results: demographics of respondents: there were (b)(4) total respondents for a completion rate of (b)(4) over half of the respondents (b)(4) identified their institution, whereas the rest (b)(4) kept their institution anonymous.The (b)(4) respondents who identified their institution practiced in (b)(4)countries, including the united states of america (b)(4), canada (b)(4), germany (b)(4), new zealand (b)(4), australia (b)(4), and puerto rico (b)(4).Within the united states, respondents were geographically diverse and from the following regions: pacific (b)(4), rocky mountain (b)(4), northeast(b)(4), southeast (b)(4), southwest(b)(4), and midwest (b)(4).Thrombocytopenia opinion and policy: a minority of respondents (b)(4) reported that their institution had a policy for platelet levels in patients undergoing np swabs.Most respondents reported that their institution did not have a policy for platelet levels (b)(4) or that they were unsure if their institution had a policy (b)(4).The median platelet cutoff below which np swabs are not performed according to institutional policy was (b)(4).Most respondents (b)(4) provided an opinion for a platelet cutoff below which np swabs should not be performed.The median cutoff based on the opinion of the respondents was (b)(4).The mean cutoff proposed by respondents was (b)(4).There was no difference in opinion for lower-level platelet cutoff among physicians who reported an institutional adverse event (b)(4) and physicians who did not report an institutional adverse event (b)(4)).Twelve (b)(4) respondents did not feel that there should be a lower-level platelet cutoff and that np swabs can be safely performed at all levels (b)(4).Several respondents commented that the etiology of thrombocytopenia should be considered and that an np swab for a patient, with chemotherapy-induced thrombocytopenia, should be approached more cautiously than an np swab for a patient with immune thrombocytopenia (itp).Some institutions transfuse platelets before np swabs in patients with thrombocytopenia who require swabs for diagnosis and management and are also thrombocytopenic.Anticoagulation policy only (b)(4) respondent (b)(4) reported an institutional policy for limiting np swabs in patients on anticoagulant therapy.This policy highlighted oral swabbing as the method for covid-19 detection in patients on anticoagulant therapy.Most (b)(4) reported that their institution did not have a policy for np swab use in patients on anticoagulation and some (b)(4) were unsure about whether their institution had a policy.Adverse events all (b)(4) reported adverse events of np swabbing were epistaxis.There were no reports of retained foreign bodies after swab fracture, anatomic injury, or cerebral spinal fluid leak.Most episodes (b)(4) of epistaxis occurred among patients with thrombocytopenia.Two episodes (b)(4) of epistaxis occurred in patients with thrombocytopenia and concomitant aspirin use.Several cases of epistaxis did not have their severity described in detail (b)(4) or were mild and resolved without intervention (b)(4).Over half of all reported epistaxis events (b)(4) were described as persistent, severe, and/or required intervention.Interventions required to stop epistaxis and stabilize the patient included platelet transfusion, red blood cell transfusion, nasal packing, emergency surgery with otorhinolaryngology, aminocaproic acid, vasoconstrictor medication, and extracorporeal membrane oxygen.One patient that developed persistent epistaxis requiring nasal packing subsequently developed fungal sinusitis; the primary oncology team questioned whether fungal sinusitis could have complicated local trauma and management of epistaxis, but causation was unable to be concluded.Alternative sources of coronavirus disease 2019 nucleic acid amplification test sources of covid-19 testing for acute diagnosis, hospital admission, or postoperative screening include np, mid-turbinate, nares, oropharyngeal, and saliva.The np (b)(4) and nares (b)(4) were the most common sources of testing that were reported.Several respondents reiterated that their institutions switched to alternative sources of covid-19 testing because of concern over np swabs (eg, mid-turbinate, nares, saliva, oropharyngeal/throat swab).Conclusion: this is one of the few studies that investigate the clinical issue around np swabs in pho patients and highlights that physicians and patients may benefit from more knowledge and guidance on this topic.Based on the available information in the source document, one composite (b)(4) and three individual case safety reports (b)(4) were created and linked in the database.This case refers to a 16-year-old male patient who developed "severe epistaxis" (pt: epistaxis) and "acute hypoxic respiratory failure" (pt: acute respiratory failure) post nasopharyngeal swab test for viral respiratory pathogen.Case report: a 16-year-old boy with a remote history of suprasellar/ hypothalamic anaplastic astrocytoma and secondary low-grade astrocytoma; metabolic derangement causing non-alcoholic steatohepatitis with cirrhosis requiring liver transplantation, obstructive sleep apnea, chronic low-grade aspiration, baseline nocturnal oxygen requirement, idiopathic thrombocytopenia (platelets: 30,000 to 50,000), and low dose aspirin (81 mg) use for transplant prophylaxis developed received a viral respiratory pathogen panel swab and developed severe epistaxis that was refractory to platelet transfusion and topical tranexamic acid, aspirated a large volume of blood, experienced an acute respiratory decline, and required extracorporeal membrane oxygenation for acute hypoxic respiratory failure.Coagulation testing at the time of bleeding revealed a normal prothrombin time/international normalized ratio and activated partial thromboplastin time.Authors' comment: this is one of the few studies that investigate the clinical issue around np swabs in pho patients and highlights that physicians and patients may benefit from more knowledge and guidance on this topic.Literature citation: greenmyer jr, kohorst ma, thompson ws, kaczor m, alajbegovic k, kranz la, et al.Nasopharyngeal swabs in pediatric patients with thrombocytopenia and anticoagulant use.J pediatr hematol oncol.2023 oct;45(7):e910-4.Company comment: this case refers to a 16-year-old male patient who developed severe epistaxis (epistaxis) and acute hypoxic respiratory failure (acute respiratory failure) post nasopharyngeal swab test for viral respiratory pathogen test.This pediatric patient had an underlying history of chronic low-grade aspiration, idiopathic thrombocytopenia and was on low dose aspirin which provides a plausible explanation for the development of epistaxis leading to respiratory failure.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of epistaxis and acute respiratory failure is assessed as possible.The case is considered serious as per medical assessment.
 
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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 
MDR Report Key18132862
MDR Text Key328111334
Report Number3015145560-2023-00009
Device Sequence Number1
Product Code KXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2023
Patient Sequence Number1
Treatment
ASPIRIN.
Patient Outcome(s) Other;
Patient Age16 YR
Patient SexMale
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