MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for PREP TRAY DRY SPONGE W/GLOVE 4461A manufactured by Carefusion, Inc.
[68085977]
(b)(4) neither the sample nor a photograph was received for the quality engineer? S evaluation. Therefore, the failure mode was unable to be confirmed. Master production records were reviewed for lot and no non-conformances were noted during the manufacturing of this lot. Our records indicate that the reviewed batch record passed all of 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. The device history record for the reported lot number was reviewed and no issues related to the falling apart condition of the sponge were found. Dhr of the sub-assembly was also reviewed and no non-conformances were found. All welding parameters were found within specification. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[68085978]
(b)(4) involves "a female patient who was having a vaginal prep for a hysteroscopy, dilation and curettage, and endometrial ablation. During the internal vaginal prep, the circulator stated she felt a slight? Pop? And she slowly began to remove the sponge stick from the patient? S vaginal canal. She stated that as she almost had the sponge stick removed, the sponge again came off of the end of the stick. The nurse was able to visualize the sponge and remove it from the patient without having to have the physician intervene. The sponge was removed from the patient without difficulty or harm to the patient. The prep was continued and completed without further incident.?
Patient Sequence No: 1, Text Type: D, B5
[71119120]
(b)(4) - lot number 965186 was provided and a dhr was completed. No issues were found related to falling apart conditions of the sponge. In addition, the device history record of the subassembly (square stick sponge dry part number 74-671) with lots 2829929, 2829927 and 2829928 were also reviewed by the manufacturing facility and no non conformances were observed. All welding parameters were found within specifications. No further information was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00160 |
| MDR Report Key | 6339462 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-01-23 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-02-17 |
| 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 G1 | CAREFUSION, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCION N PIMSA III |
| 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 | 2017-02-17 |
| Model Number | 4461A |
| Lot Number | 0000965186 |
| 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 | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-17 |