MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-01-10 for KWIK VIAL, 15ML, CASE (30015) manufactured by Baxter Healthcare Corporation.
[4056808]
On (b)(6) 2013, baxter (b)(4) was notified through an email from baxter healthcare corporation, regarding medwatch 5032498. Medwatch 5032498 reported leaking kwik vials. No patient involvement or operator injury was reported. A follow up with the customer indicated that there are no samples available for an evaluation.
Patient Sequence No: 1, Text Type: D, B5
[11480950]
Device evaluated by manufacturer. No product was returned for an evaluation. No evaluation performed as there were devices returned. On (b)(4) 2013, baxter (b)(4) was notified through an email from baxter healthcare corporation, regarding medwatch 5032498. Medwatch 5032498 reported leaking kwik vials. No patient involvement or operator injury was reported. A follow up with the customer indicated that there are no samples available to be returned for an evaluation. The customer had noticed that at the time of production, the seals were not sealed around the rim. There are no samples available for an evaluation. The supplier of these components has been notified of the issue and has implemented corrective actions to prevent recurrence of this issue. Our risk assessment of these reported issues show that the potential of patient harm is sufficiently low due to the following risk control measures: 1. The supplier was notified and determined that minimal impact to productivity or customer perception, risk to safety and efficiency. 2. The supplier will add an inspection to the control plan for the knit line. Based on an evaluation of the product risk management files for these kwik vials, this issue is not occurring with greater frequency or severity than anticipated for the device. Device not available
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419106-2014-00001 |
| MDR Report Key | 3567504 |
| Report Source | 00 |
| Date Received | 2014-01-10 |
| Date of Report | 2014-01-10 |
| Date Mfgr Received | 2013-12-27 |
| Date Added to Maude | 2014-04-16 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS PHONE VANG |
| Manufacturer Street | 9540 S MAROON CIRCLE # 400 |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal | 80112 |
| Manufacturer Phone | 3037846639 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KWIK VIAL, 15ML, CASE (30015) |
| Generic Name | KWIK VIAL, 15ML, CASE (30015) |
| Product Code | KAI |
| Date Received | 2014-01-10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | 14445 GRASSLANDS DRIVE ENGLEWOOD CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-10 |