MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for TRUE DILATATION BALLOON VALVULOPLASTY CATHETER manufactured by Bard Peripheral Vascular, Inc..
[110387937]
Patient Sequence No: 1, Text Type: N, H10
[110387938]
Bard peripheral vascular had shipped in new consignment to cath lab. When the product arrived, we noticed the label on the box was peeling off. When we looked at the label, we noticed that a new sticker with a new expiration date was placed over an old sticker with an expiration date of over a year ago. Three new stickers had been placed over old stickers. The inner package holding sterile product was sealed but the outer packaging was opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7578150 |
| MDR Report Key | 7578150 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-05-04 |
| Report Date | 2018-05-07 |
| Date Reported to FDA | 2018-05-07 |
| Date Reported to Mfgr | 2018-05-07 |
| Date Added to Maude | 2018-06-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | TRUE DILATATION BALLOON VALVULOPLASTY CATHETER |
| Generic Name | BALLOON AORTIC VALVULOPLASTY |
| Product Code | OZT |
| Date Received | 2018-06-07 |
| Returned To Mfg | 2018-05-05 |
| Lot Number | GFBP3257A |
| ID Number | PERFUSION CATHETER 24 X 3.5 X |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD STREET TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-07 |