MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-07-16 for GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS manufactured by Covidien.
[151122174]
Brand name is unknown at this time. Exact product code is unknown at this time. 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
[151122175]
The customer reported that the patient had an enfit nasogastric tube (ngt) placed for tube feedings while intubated and sedated in the intensive care unit (icu). The patient started to have coffee ground emesis so the ngt was placed to the wall suction. Only a limited amount came out and the patient vomited and aspirated. The patient required inter-venous (iv) antibiotics and a bronchoscopy. The customer stated there was no obvious signs that the tube was leaking or that an occlusion occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2019-02217 |
| MDR Report Key | 8793284 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2019-07-16 |
| Date of Report | 2019-07-16 |
| Date Mfgr Received | 2019-07-01 |
| Date Added to Maude | 2019-07-16 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS |
| Product Code | PIF |
| Date Received | 2019-07-16 |
| Lot Number | PT00030482 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 1. Other | 2019-07-16 |