MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-05 for STYLET COATED 6 FR 2.5-4.5 OD DYND43506 manufactured by Medline Industries.
[169819343]
On (b)(6) 2019 intubation of premature infant. On (b)(6) 2019 chest x-ray identified a foreign body in pt's left lung; discovered that the foreign body was the casing that came off the stylet during intubation. We also discovered that the casing is not radiopaque making it unidentified in previous x-rays. Pt transferred to another facility for higher level of care. Lot # s 59219050916, 59219061337, 59219010204, 59219040715, 59219030450, 59217091512, 59218102251. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091490 |
| MDR Report Key | 9426213 |
| Date Received | 2019-12-05 |
| Date of Report | 2019-12-03 |
| Date of Event | 2019-11-13 |
| Date Added to Maude | 2019-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59219050916 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59219061337 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59219010204 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59219040715 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59219030450 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59217091512 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | STYLET COATED 6 FR 2.5-4.5 OD |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-12-05 |
| Catalog Number | DYND43506 |
| Lot Number | 59218102251 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-05 |