MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2017-02-23 for BD BONNANO? SUPRAPUBIC CATHETER TRAY 408289 manufactured by Bd Caribe Ltd..
[68212480]
Date of event: unknown. The date received by manufacturer has been used for this field. Results: a sample is not available for evaluation. A review of the device history record could not be performed as a lot number was not provided for this incident. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer? S indicated failure mode. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68212481]
It was reported that a physician suffered a contaminated needle stick injury from an 18 gauge needle in a bd bonnano suprapubic catheter tray. The physician followed protocol for an occupational blood exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2017-00001 |
| MDR Report Key | 6355477 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-09 |
| Date Mfgr Received | 2017-02-09 |
| Date Added to Maude | 2017-02-23 |
| 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 | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BONNANO? SUPRAPUBIC CATHETER TRAY |
| Generic Name | SUPRAPUBIC CATHETER |
| Product Code | FEZ |
| Date Received | 2017-02-23 |
| Catalog Number | 408289 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-23 |