MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-12 for TRAY SKIN PREP DRY W/SPONGE 4461A manufactured by Carefusion.
[2566754]
The surgeon was preparing the patient with the sponge stick from preoperative tray. The sponge separated from the stick upon insertion into the vagina. This was not apparent at the time and the doctor scrubbed with the sponge stick. When the sponge stick was removed it was immediately noticed that the sponge remained in the vagina. The sponge was promptly removed and the preparation was continued with the remaining sponge sticks without any problems. There were three scratches in the vagina. Unfortunately, there is no sample available for evaluation. However samples our current process was performed a pull test. The device history record for the lot 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. In addition, the subassemblies 09s03583 (contour stick sponge) and 09s03987 ( square stick sponge) were reviewed and no problems were found related with the issue reported. The seal parameters were found within specifications. At this time the contour stick sponge is not being manufactured, however we could observe in our manufacturing area that the pre-assembly operation between the stick and contour sponge is performed in work tables in the same workstation where the seal equipment was placed, probably causing unsealed and sealed contour stick sponges to get mixed. The square stick sponge is sealed in roulette equipment, in one side is placed the pre-assembly square stick sponge (unseal) and in the opposite side the seal square stick sponge is taken by an operative personnel making a mixture of this stick sponges less probable. At this time it is not possible to determine the root cause to the issue reported. However reviewing processes of square and contour stick sponge we determined the following: a possible root cause for contour stick sponges fell off is that our operative personnel mixed the pre-assembly of contour stick sponge (unsealed) with the seal stick sponges during the manufacturing process. About the square stick sponge during the seal operation it is not possible to mix the subassembly due in one side is placed the pre-assembly square stick sponge (unsealed) and in the opposite side the seal square stick sponge is taken by an operative personnel.
Patient Sequence No: 1, Text Type: D, B5
[9532826]
(b)(4). Carefusion 2200 inc. Post-market surveillance was historically managed by cardinal health via a transitional service agreement from september 1, 2009, through july 1, 2011, since carefusion officially spun off from cardinal health as of september 1, 2009. A retrospective review of all complaints during this timeframe was conducted by the new carefusion customer advocacy clinical team in accordance with internal standard operating procedures and it was determined that this event necessitates submission as a medical device reportable (mdr) in accordance with 21 code of federal regulation (cfr) part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2012-00072 |
| MDR Report Key | 2413483 |
| Report Source | 06 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-12 |
| Date of Event | 2010-12-02 |
| Date Mfgr Received | 2010-12-14 |
| Date Added to Maude | 2012-05-11 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 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 | TRAY SKIN PREP DRY W/SPONGE |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | OJU |
| Date Received | 2012-01-12 |
| Model Number | 4461A |
| Lot Number | Y10N1777 |
| 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 | 2012-01-12 |