MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-07-21 for MALLINCKRODT 85865 manufactured by Mmj Sa De Cv (usd).
[80756772]
(b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[80756773]
Medtronic received a report, prior to intubation, foreign material was on stylet was subsequently inserted (unknowingly) into the tube.
Patient Sequence No: 1, Text Type: D, B5
[117745190]
The sample was received for analysis and the reported issue was confirmed. A visual inspection was performed and it was observed the stylet did not present damages in the plastic covering sheath and plastic part of the pouch is torn. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[117745191]
Medtronic received a report, prior to intubation, foreign material was on stylet was subsequently inserted (unknowingly) into the tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05342 |
| MDR Report Key | 6734706 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-07-21 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-06-26 |
| Date Mfgr Received | 2017-10-16 |
| Device Manufacturer Date | 2016-12-16 |
| Date Added to Maude | 2017-07-21 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | MMJ SA DE CV (USD) |
| Manufacturer Street | AVE HENEQUEN NO 1181 DESARROLL |
| Manufacturer City | CIUDAD JUAREZ 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 | 2017-07-21 |
| Returned To Mfg | 2017-10-16 |
| Model Number | 85865 |
| Catalog Number | 85865 |
| Lot Number | 16L0514JZX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MMJ SA DE CV (USD) |
| Manufacturer Address | AVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-21 |