MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-02 for BROSELOW WHITE INTUBATION MODULE 2PK 7700WIN manufactured by Carefusion/bd.
[74177812]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[74177813]
Customer reported that the product was missing two endotracheal tubes. This issue was discovered during a code. There were two nasal gastric tubes and no endotracheal tubes.
Patient Sequence No: 1, Text Type: D, B5
[110217618]
A sample was received for evaluation, the missing component was confirmed, however the packaging was open when received. A dhr review could not be completed as the lot number reported was not manufactured at the current facility. Two-years of complaints were reviewed and no trend was detected. At this time it is not possible to determine the root cause of the missing component since the lot number reported was manufactured at a previous facility. However, the current processes and procedures were reviewed and no issues were found that would contribute to this issue in the current facility. In addition, the current manufacturing personnel were made aware of this issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00331 |
| MDR Report Key | 6536759 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-02 |
| Date of Report | 2017-08-04 |
| Date of Event | 2017-04-06 |
| Date Mfgr Received | 2017-07-12 |
| Date Added to Maude | 2017-05-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION/BD |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BROSELOW WHITE INTUBATION MODULE 2PK |
| Generic Name | EMERGENCY RESPONSE SAFETY KIT |
| Product Code | OKI |
| Date Received | 2017-05-02 |
| Returned To Mfg | 2017-06-12 |
| Catalog Number | 7700WIN |
| Lot Number | 11195095 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/BD |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-02 |