MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for PREP TRAY DRY SPONGE W/GLOVE 4461A manufactured by Carefusion, Inc.
[54412941]
(b)(4) a follow up emdr will be submitted upon completion of investigation or additional information received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[54412942]
Medwatch (b)(4) states, " surgeon preped the perineum with betadine stick sponges. The sponges came off in the vagina two times. They were retrieved by the surgeon. "
Patient Sequence No: 1, Text Type: D, B5
[58380126]
(b)(4) neither the sample nor a photograph was received for evaluation. Therefore, the failure mode was unable to be confirmed. Master production records were reviewed for lot 914885 and no non-conformances were noted during the manufacturing of this lot. Our records indicate that the reviewed batch record passed all the in process inspection. During manufacturing of product assembly and packaging no special issues were noted and no ncr were issued to this lot number. Dhr of the sub-assembly was reviewed and no non-conformances were found. The most probable root cause was unable to be determined due to lack of sample. All internal manufacturing procedures were adhered to and no issues were found. The failure mode will be entered into the complaint management system and will be tracked / trended for any additional similar failure modes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004932373-2016-00010 |
| MDR Report Key | 5923300 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-10-26 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2016-08-04 |
| Date Added to Maude | 2016-09-01 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628063 |
| Manufacturer G1 | CAREFUSION MEXICALI MX PLANT |
| Manufacturer Street | CERRADA V |
| Manufacturer City | MEXICALI B.C; |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREP TRAY DRY SPONGE W/GLOVE |
| Generic Name | SKIN AND PREP TRAY |
| Product Code | OJU |
| Date Received | 2016-09-01 |
| Model Number | 4461A |
| Lot Number | 0000914885 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-01 |