MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2000-05-18 for BARD BUTTON DEVICE DECOMP 61 00351 61 000351 manufactured by Bipd Div Cr Bard.
[166116]
Parent states took tube out of package for first time use. Placed decompression tube into bard button, began to draw up on syringe and noted no residual. Removed tube from button and noted the hole on proximal end of adapter was too small. Used another decompression tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1223688-2000-00020 |
| MDR Report Key | 279470 |
| Report Source | 04 |
| Date Received | 2000-05-18 |
| Date of Report | 2000-05-18 |
| Date of Event | 2000-03-27 |
| Date Facility Aware | 2000-03-30 |
| Report Date | 2000-05-18 |
| Date Mfgr Received | 2000-03-31 |
| Date Added to Maude | 2000-05-31 |
| 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 | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DONNA LANTEIGNE |
| Manufacturer Street | 129 CONCORD RD BLD3 |
| Manufacturer City | BILLERICA MA 01821 |
| Manufacturer Country | US |
| Manufacturer Postal | 01821 |
| Manufacturer Phone | 9786638989 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | UNK |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD BUTTON DEVICE DECOMP |
| Generic Name | DECOMPRESSION TUBE |
| Product Code | FEF |
| Date Received | 2000-05-18 |
| Model Number | 61 00351 |
| Catalog Number | 61 000351 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 270470 |
| Manufacturer | BIPD DIV CR BARD |
| Manufacturer Address | 129 CONCORD RD., BLDG. 3 BILLERICA MA 01821 US |
| Baseline Brand Name | BARD BUTTON DEVICE DECOMP |
| Baseline Generic Name | DECOMPRESSION TUBE |
| Baseline Model No | 61 00351 |
| Baseline Catalog No | 61 000351 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-18 |