MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-01-10 for HUDSON STYLET,SOFT TIP,6 FR 5-15120 manufactured by Teleflex Medical.
[132776107]
Qn# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132776108]
Customer complaint alleges "a piece of plastic was found in the mouth of a (b)(6) new-born baby while he had a big cough. According to doctors, this piece of plastic is a part of the stylet of the intubation tube. (continued) it's 4-5 cm length (see pic 2). The doctor who performed the action reported an unsusual resistance whilst he removed the stylet. " customer submitted a photo for reference. The patient condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2019-00063 |
| MDR Report Key | 8236972 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-10 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-15 |
| Date Mfgr Received | 2019-02-06 |
| Date Added to Maude | 2019-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON STYLET,SOFT TIP,6 FR |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-01-10 |
| Returned To Mfg | 2019-01-23 |
| Catalog Number | 5-15120 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-10 |