MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-08-28 for DOBBHOFF 12FR;43IN W/STYLET 8884711253 manufactured by Covidien.
[118529801]
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
[118529802]
The customer reports that after the release for use, the ng tube presented resistance to infusing medication even under positive pressure (syringe). The ng tube was withdrawn and a fold (kink) close to the tip approximately 10cm was noticed.
Patient Sequence No: 1, Text Type: D, B5
[121916987]
Samples were not received for the investigation. The device history record was reviewed and indicated that the product was released accomplishing all quality standards. Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis. A corrective action is not applicable at this time. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. This complaint will be used for qa tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2018-02005 |
| MDR Report Key | 7823227 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-08-28 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-08-22 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-08-28 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| 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 | DOBBHOFF 12FR;43IN W/STYLET |
| Generic Name | TUBE, FEEDING |
| Product Code | FPD |
| Date Received | 2018-08-28 |
| Model Number | 8884711253 |
| Catalog Number | 8884711253 |
| Lot Number | 1712287964 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-08-28 |