MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-07 for CHLORAPREP manufactured by .
[3566021]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10761859]
On (b)(4) 2013, medical action industries (mai) (b)(4) facility received medwatch #(b)(4) from the fda. We manufacture the iv convenience kit that contained the incident device, the chloraprep frepp applicator. Immediately upon receipt of the medwatch, we contacted our supplier of the chloraprep device with (b)(4). Currently, we have not received any additional complaints on the kit lot or the applicator lot involved. Our supplier, (b)(4), responded directly to the customer on (b)(4) 2013 with a letter detailing their investigation results. (b)(4) stated that without receiving the actual applicator involved, a root cause could not be determined. Their investigation could find no indication that would suggest an issue with glass particles in the applicator foam. Based on their historical data and past investigations, the design and/or mfg processes for this product may allow for this type of failure; however, appropriate controls are in place to maintain the work areas at an acceptable stated of cleanliness at all times, reducing the possibility of glass particles in the finished product. They continue to explore opportunities to further reduce the rate of occurrences for these types of failures. They also provided the customer with a chloraprep frepp in-service poster and offered to have their sales rep meet with the customer and her staff to address the issue and provide re-education on the use of the frepp. (b)(4) had also previously opened a capa (corrective and preventive action) investigation to determine the root cause and recommend corrective/preventive actions for this issue as much as can be determined. The (b)(4) scar response will be reviewed and maintained on file, and any additional info they are able to provide will be communicated with the complainant. Additionally, this complaint has been entered into our post market surveillance system for appropriate tracking, trending and any required follow-up per our standard procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2013-00002 |
| MDR Report Key | 3115263 |
| Report Source | 00 |
| Date Received | 2013-05-07 |
| Date Mfgr Received | 2013-04-19 |
| Date Added to Maude | 2013-05-17 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS, DIRECTOR |
| Manufacturer Street | 25 HEYWOOD RD. |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8286818820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHLORAPREP |
| Generic Name | KIT, I.V. START |
| Product Code | LRS |
| Date Received | 2013-05-07 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-07 |