MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2002-11-21 for BBL PORT-A-CUL TUBES AND SWABS STERILE PACK 221607 manufactured by Becton Dickinson.
[15606647]
While obtaining an endotracheal culture with a swab, cotton end (tip) of swab broke and was aspirated into bronchus. A bronchoscopy was performed and tip was removed without difficulty. The pt was not harmed in the incident. The pt expired but the death was not related to the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2002-00006 |
| MDR Report Key | 429577 |
| Report Source | 00,06 |
| Date Received | 2002-11-21 |
| Date of Report | 2002-11-14 |
| Date of Event | 2002-08-01 |
| Date Mfgr Received | 2002-10-15 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2002-11-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL PORT-A-CUL TUBES AND SWABS STERILE PACK |
| Generic Name | SPECIMEN COLLECTION AND TRANSPORT DEVICE |
| Product Code | JSL |
| Date Received | 2002-11-21 |
| Model Number | NA |
| Catalog Number | 221607 |
| Lot Number | 7249 (SWAB) |
| ID Number | * |
| Device Expiration Date | 2006-03-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 418580 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 21152 US |
| Baseline Brand Name | BBL PORT-A-CUL TUBES AND SWABS STERILE PACK |
| Baseline Catalog No | 221607 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-11-21 |