MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-07-16 for PREP TRAY DRY SPONGE W/GLOVE 4461A manufactured by Carefusion, Inc.
[114298395]
Initial mdr submission, a follow up will be submitted if additional information becomes available. A sample is not available for this investigation but a dhr will come completed on the device.
Patient Sequence No: 1, Text Type: N, H10
[114298396]
Customer reported that the sponge was coming off the tips of the stick. Additional information received stating that the product was being used at the time of the incident on a patient during a gynecological procedure. Swab tip was retrieved from patient, no harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2018-00993 |
| MDR Report Key | 7690337 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-07-16 |
| Date of Report | 2018-09-07 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-07-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREP TRAY DRY SPONGE W/GLOVE |
| Generic Name | SKIN PREP TRAY (KIT) |
| Product Code | OJU |
| Date Received | 2018-07-16 |
| Catalog Number | 4461A |
| Lot Number | 0001192345 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | ZONA FRANCA LAS AMERICAS SANTO DOMINGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-16 |