MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-05-24 for BECTON DICKINSON 408289 manufactured by Becton Dickinson Caribe Ltd..
[21709253]
Pt had a vaginal hysterectomy with anterior/posterior repair and placement of the bonanno suprapublic bladder drainage catheter. Pt went home on 3/27/2000. On sunday 4/2/00, pt called physician because catheter was leaking at the insertion site. Physician thought perhaps bladder was more full than pt thought. Told pt to unclamp and drain more often. Even after emptying the bag the pt's bladder felt full. On monday 4/3/00, pt called physician and told physician the catheter wasn't working. Physician told the pt to come to the office where physician attempted to remove the catheter. As physician attempted the removal, physician found it was broken necessitating the pt to go to a urologist for a cystoscopy to remove the pigtail portion of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2000-00004 |
| MDR Report Key | 279865 |
| Report Source | 05,06 |
| Date Received | 2000-05-24 |
| Date of Report | 2000-05-18 |
| Date of Event | 2000-04-03 |
| Date Mfgr Received | 2000-04-20 |
| Date Added to Maude | 2000-06-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN WINTERS |
| Manufacturer Street | 1 BECTON DR |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal | 07417 |
| Manufacturer Phone | 2018476364 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BECTON DICKINSON |
| Generic Name | BONANNO SUPRAPUBIC BLADDER DRAINAGE CATHETER |
| Product Code | FEZ |
| Date Received | 2000-05-24 |
| Model Number | NA |
| Catalog Number | 408289 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270845 |
| Manufacturer | BECTON DICKINSON CARIBE LTD. |
| Manufacturer Address | RD. 31, KM. 24.3 P.O. BOX 4010 JUNCOS PR 007774010 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 | 2000-05-24 |