FDA Adverse Event
Malfunction
Summary report: N
RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE
MDR report key: 13026172
·
Received December 17, 2021
Report
- Report Number
- 8040412-2021-00328
- Event Type
- Malfunction
- Date Received
- December 17, 2021
- Date of Event
- November 26, 2021
- Report Date
- November 26, 2021
- Manufacturer
- TELEFLEX MEDICAL SDN. BHD.
- Product Code
- BTQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
QN#(B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE SAMPLE CONTAINED VAPORS INSIDE THE PACKAGING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE VISUAL EXAM, THE COMPLAINT HAS BEEN CONFIRMED. A CAPA WAS OPENED TO FURTHER ADDRESS THIS ISSUE.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED: "WE HAVE 4 UNITS AT THE PHARMACY DEPARTMENT WHICH HAVE NOTICEABLE HUMIDITY IN THEIR PACKAGING". NO PATIENT INVOLVEMENT REPORTED.
Description of Event or Problem · 0
IT WAS REPORTED: "WE HAVE 4 UNITS AT THE PHARMACY DEPARTMENT WHICH HAVE NOTICEABLE HUMIDITY IN THEIR PACKAGING". NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1925397 | RUSCH NASOPHARYNGEAL AIRWAY, LATEX FREE | AIRWAY, NASAL | BTQ | TELEFLEX MEDICAL SDN. BHD. | KMA20K0267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |