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 PVP-1 SCRUB CARE 4468 manufactured by Carefusion.
[2566301]
Incident occured on (b)(6) 2011. Was informed on (b)(4) 2011 was reported within 24 hours. Dr. Prepped vaginal vault area of patient with foam sponge stick and foam portion came off stick inside of the patient. Dr. Had to retrieve foam piece from inside of patient. 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 complaint this incident was identified the contour stick sponges were without seal. Therefore to confirm the issue reported on this complaint is necessary the sample or picture. The device history records for the lot reported were 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. Our manufacturing process was reviewed and we couldn't find anything that could have contributed to this issue. (b)(4). In addition the pre-assembly contour stick sponges (unsealed) are (b)(4). An internal investigation (b)(4) was initiated in order to determine the root cause for this kind of report. At this time is not possible to determine the corrective actions for this issue reported. However an internal investigation (b)(4) was initiated in order to determine the corrective actions for this kind of report.
Patient Sequence No: 1, Text Type: D, B5
[9582951]
(b)(4). A retrospective review of all complaints during this timeframe was conducted by the new carefusion (b)(4) 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 | 8030673-2012-00073 |
| MDR Report Key | 2413463 |
| Report Source | 06 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-12 |
| Date of Event | 2011-05-26 |
| Date Mfgr Received | 2011-06-08 |
| 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 PVP-1 SCRUB CARE |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | OJU |
| Date Received | 2012-01-12 |
| Model Number | 4468 |
| Lot Number | Y10N2147 |
| 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 |