MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-12 for TRAY,SKIN SCRUB,VAG,PVP-I 4469A manufactured by Carefusion.
[2564789]
The following event description was taken from a medwatch sent to us by the fda: sponges are coming off the sticks rom the scrub prep kits. " writer received a return phone call from (b)(6) at the facility regarding this event she indicated that there was no harm to the patient and the procedure continued without interruption. Writer asked about the sample return and she indicated that in most cases the samples do come to her for return to the manufacturer, but unfortunately in this cas,e she did not receive them to forward on to carefusion for evaluation.? She did indicate that there is a chance that the samples are with her cooperate purchaser but she can't verify this. At this time, no samples are available for evaluation. 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 could observed that the work station for contour stick sponge, was re-designed where was separated from the work tables in order to maintain the pre-assembly of the contour stick sponges (unsealed) separated from the sealed stick sponges. In addition, the pre-assembly contour stick sponges (unsealed) are not accumulate in order to prevent that the sponges mixes with the stick sponges sealed. A tension test is performed during our manufacturing process in order to verify the seal on the stick sponges ( contour & square). In addition, samples are taken from production every 2 hours to conduct a destructive pull test to detect any anomalies in the welding process. The sample size is based on an aql. 65, which is a 95% ci and we accept with 0 defects and reject with 1.
Patient Sequence No: 1, Text Type: D, B5
[9582036]
(b)(4). "originally the decision was made that this complaint did not meet the requirements for mdr submission in adherence with 21 code of federal regulation part 803. However, due to a similar event subsequently being submitted as an mdr, the decision has been made to retrospectively submit this event as an mdr. " an inquiry was received from the fda and sent previously, this document has been attached to this mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2012-00071 |
| MDR Report Key | 2413451 |
| Report Source | 05,06 |
| Date Received | 2012-01-12 |
| Date of Report | 2012-01-12 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-07-12 |
| 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 SCRUB,VAG,PVP-I |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, STERILE |
| Product Code | OJU |
| Date Received | 2012-01-12 |
| Model Number | 4469A |
| 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 |