MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-04 for MALLINCKRODT 85864 manufactured by Mmj Sa De Cv(usd).
[107379444]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[107379445]
According to the reporter, during an emergency intubation by the physician, the length of the device was short for intubation so he had to modify it by bending out the loop so it could be long enough to complete the intubation. It was reported that there was a delay in care but no intubation was required. The customer reported that there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2018-00322 |
| MDR Report Key | 7487749 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-04 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-04-20 |
| Date Mfgr Received | 2018-04-26 |
| Date Added to Maude | 2018-05-04 |
| 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 | AVI KLUGER |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MMJ SA DE CV(USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROL |
| Manufacturer City | CIUDAD JUAREZ,MX 32590 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MALLINCKRODT |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-05-04 |
| Model Number | 85864 |
| Catalog Number | 85864 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV(USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ,MX 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-04 |