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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 Hemorrhage/Bleeding (1888); 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 2327 active pho physicians who were part of the children's oncology group in aug-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 130 total respondents for a completion rate of 5.6 percent (in equal to 130/2327).Over half of the respondents (56.9 percent, n equal to 74/130) identified their institution, whereas the rest (43.1 percent, n equal to 56/130) kept their institution anonymous.The 74 respondents who identified their institution practiced in 7 countries, including the united states of america (n equal to 63), canada (n equal to 6), germany (n equal to 1), new zealand (n equal to 1), australia n equal to 2), and puerto rico (n equal to 1).Within the united states, respondents were geographically diverse and from the following regions: pacific (n equal to 9), rocky mountain (n equal to 1), northeast (n equal to 15), southeast (n equal to 10), southwest (n equal to 6), and midwest (n equal to 22).Thrombocytopenia opinion and policy: a minority of respondents (n equal to 17/130, 13.1 percent) 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 (n equal to 105/130, 80.8 percent) or that they were unsure if their institution had a policy (n equal to 8/130, 6.1 percent).The median platelet cutoff below which np swabs are not performed according to institutional policy was 30,000 (iqr: 20,000 to 40,000; minimum: 10,000; maximum: 50,000).Most respondents (n equal to 114/130, 87.7 percent) 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 10,000 (iqr: 10,000 to 20,000; minimum: 0; maximum: 75,000).The mean cutoff proposed by respondents was 16,616.There was no difference in opinion for lower-level platelet cutoff among physicians who reported an institutional adverse event (mean equal to 19,808; n equal to 25) and physicians who did not report an institutional adverse event (mean equal to 15,651; n equal to 105) (p equal to 0.15).Twelve (n equal to 12/130, 9.2 percent) respondents did not feel that there should be a lower-level platelet cutoff and that np swabs can be safely performed at all levels (eg, a platelet counts of 1000 is sufficient for an np swab).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 1 respondent (n = 1/130, 0.7 percent) 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 (n = 113/130, 86.9 percent) reported that their institution did not have a policy for np swab use in patients on anticoagulation and some (n = 16/130, 12.3 percent) were unsure about whether their institution had a policy.Adverse events: all 24 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 (95.8 percent, n equal to 23/24) of epistaxis occurred among patients with thrombocytopenia.Two episodes (8.3 percent, n equal to 2/24) of epistaxis occurred in patients with thrombocytopenia and concomitant aspirin use.Several cases of epistaxis did not have their severity described in detail (n equal to 7/24, 29.2 percent) or were mild and resolved without intervention (n equal to 3/24, 12.5 percent).Over half of all reported epistaxis events (n equal to 13/24 54.2 percent) 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 (66.9 percent) and nares (33.1 percent) 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 7-year-old male patient who developed "severe left naris epistaxis" (pt: epistaxis) and "posterior pharyngeal bleeding" (pt: pharyngeal haemorrhage) post nasopharyngeal swab test for covid-19.Case report: a 7-year-old boy with metastatic hepatoblastoma on carboplatin and doxorubicin presented to the emergency department for fever.A covid-19 np swab was performed as part of his evaluation before platelet levels resulted.The patient developed severe left naris epistaxis and posterior pharyngeal bleeding with the passage of quarter-sized clots.Emergency department blood counts revealed pancytopenia with a platelet count of 2×10e9/l, hemoglobin of 8.1 g/dl, and absolute neutrophil count of 0.01×10e9/l.Hemoglobin dropped by 1.1 g/dl during the initial bleed.Coagulation studies were normal.His epistaxis was managed with oxymetazoline, mechanical pressure, and multiple transfusions of platelets and packed red blood cells.His np bleeding persisted for over 24 hours.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 7-year-old male patient who developed severe left naris epistaxis (epistaxis) and posterior pharyngeal bleeding (pharyngeal haemorrhage) post nasopharyngeal swab test for covid-19.This pediatric patient was later found to have pancytopenia use which provides a plausible explanation for the development of epistaxis.Considering the case information, the role of nasopharyngeal swab cannot be ruled out and the causality of epistaxis and pharyngeal haemorrhage 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 08540
MDR Report Key18131654
MDR Text Key328109465
Report Number3015145560-2023-00008
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
CARBOPLATIN; DOXORUBICIN
Patient Outcome(s) Other;
Patient Age7 YR
Patient SexMale
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