MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2003-11-04 for BD BONANNO CATHETER 408289 manufactured by Becton Dickinson Caribe Ltd.
[295099]
Bonanno suprapubic bladder drainage catheter was used as a chest drain. The catheter was inserted on the ward in 3/2003 into the chest of the pt. Two weeks later a nurse removed the sutures and the catheter came away almost immediately, leaving 14-15cms of it within the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2003-00006 |
| MDR Report Key | 493867 |
| Report Source | 01,05,06 |
| Date Received | 2003-11-04 |
| Date of Report | 2003-11-04 |
| Date of Event | 2003-03-28 |
| Date Mfgr Received | 2003-10-21 |
| Date Added to Maude | 2003-11-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL PASINO |
| Manufacturer Street | 1 BECTON DR |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018474269 |
| Manufacturer G1 | BECTON DICKINSON CARIBE LTD. |
| Manufacturer Street | RD 31 K.M. 24.3 P.O. BOX 4010 |
| Manufacturer City | JUNCOS PR 00777401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 4010 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BONANNO CATHETER |
| Generic Name | BONANNO SUPRAPUBIC BLADDER DRAINAGE CATHETER |
| Product Code | FEZ |
| Date Received | 2003-11-04 |
| Model Number | NA |
| Catalog Number | 408289 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 482575 |
| Manufacturer | BECTON DICKINSON CARIBE LTD |
| Manufacturer Address | * JUNCOS PR * US |
| Baseline Brand Name | BONANNO CATHETER |
| Baseline Generic Name | SUPRAPUBLIC BLADDER DRAINAGE CATHTER |
| Baseline Model No | NA |
| Baseline Catalog No | 408289 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-11-04 |