MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-08-08 for HYDRA SIT-361-100 manufactured by Boston Scientific - Marlborough.
[116556169]
(b)(4). The device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[116556190]
It was reported to boston scientific corporation that a hydra irrigation tubing was unpacked for inventory. According to the complainant, during unpacking, pink fibers or blue fuzz was found inside the sterile area of the sealed packaging. There was no patient or procedure involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02477 |
| MDR Report Key | 7763167 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-08-08 |
| Date of Report | 2018-07-16 |
| Date Mfgr Received | 2018-07-16 |
| Device Manufacturer Date | 2017-12-20 |
| Date Added to Maude | 2018-08-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRA |
| Generic Name | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE |
| Product Code | FEQ |
| Date Received | 2018-08-08 |
| Model Number | SIT-361-100 |
| Lot Number | 0000171210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-08 |