MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-23 for PED-TBE 6FR;20IN WGT W/STYLET 8884730741 manufactured by Covidien.
[184500757]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[184500758]
The customer reported that there were perforations in the tube and leaking was observed through the y port of the feeding tube during use. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2020-02438 |
| MDR Report Key | 9866595 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-23 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD IND |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PED-TBE 6FR;20IN WGT W/STYLET |
| Generic Name | TUBES, GASTROINTESTINAL (AND ACCESSORIES) |
| Product Code | KNT |
| Date Received | 2020-03-23 |
| Model Number | 8884730741 |
| Catalog Number | 8884730741 |
| Lot Number | 1812284464 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD IND TIJUANA 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |