MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-10-05 for WET PREP TRAY WITH ESTEEM GLOVE 4465ANE manufactured by Carefusion.
[2346372]
Complaint description from end user: "(b)(6), surgical coordinator, called? Writer on (b)(6) 2011.? She stated she was present during the episode, there was no harm to the patient.? The piece was easily removed during the procedure and the procedure went on without delay and with no residual effects anticipated.? The prep into the vaginal canal is quite deep in some patients so the prep stick is often seated deep inside the canal so as to swipe the cervix with bedatine.? The stick broke at the "neck. "? She said, it was very peculiar but no further events have occured. "
Patient Sequence No: 1, Text Type: D, B5
[9353783]
(b)(4). No sample was provided by the customer; therefore an evaluation of the complaint device for deficiency of construction could not be performed. However samples of our current production process were reviewed and no problems related with this issue were observed. However, in similar complaints with this incident were identified the contour stick sponges were without a seal. Therefore, to confirm the issue the batch reported was evaluated for any issues related with this customer report. The product was manufactured, inspected and released in accordance with our internal procedures and no issues were observed on this complaint. (b)(4). A tension test is performed during our manufacturing process in order to verify the seal on the stick sponges. In addition, samples are taken from production every 2 hours to conduct a destructive pull test to detect any anomalies in the welding process. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2011-00020 |
| MDR Report Key | 2277601 |
| Report Source | 08 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-10-05 |
| Date of Event | 2011-07-29 |
| Date Mfgr Received | 2011-07-29 |
| Date Added to Maude | 2011-10-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WET PREP TRAY WITH ESTEEM GLOVE |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | OJU |
| Date Received | 2011-10-05 |
| Model Number | 4465ANE |
| Lot Number | 0000317223 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-05 |