MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-12-30 for VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT) 6N8220 manufactured by Baxter Healthcare.
[17871112]
The customer reported to baxter (b)(4) a vitalhold standard bore extension set with v-link catheter securement (convenience kit) that would not allow flow through the v-link after the solution bag was spiked. The customer was using a continu-flo 109" inch primary set in conjunction with the v-link extension set. The condition occurred during priming. There was no patient injury or medical intervention necessary. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[17921974]
(b)(4). The customer sent in five used samples for evaluation. All samples were attached to an in-house primary set which was spiked into a 1000ml solution bag containing reverse osmosis water. Samples 1-4 primed normally with normal flow noted. However, sample 5 would not prime. A visual inspection under a microscope of the gland on sample 5 revealed a re-knit condition of the center slit. Based on the evaluation results the condition was confirmed. This condition was caused by re-knit of the center slit. There is no 510k number associated with this product as it is 510k exempt. However, the individual component from the kit with the reported defect has a 510k number. Therefore, in this mdr, the 510k number utilized is referring to the specific component of the kit relating to the reported condition. A follow-up report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000001-2010-06420 |
| MDR Report Key | 1942693 |
| Report Source | 05,07 |
| Date Received | 2010-12-30 |
| Date of Report | 2010-03-30 |
| Date of Event | 2010-03-01 |
| Date Mfgr Received | 2010-03-30 |
| Date Added to Maude | 2011-07-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE |
| Manufacturer Street | 600 MTS OESTE DE ENTRADA |
| Manufacturer City | CARTAGO |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT (CONVENIENCE KIT) |
| Generic Name | INTRAVENOUS EXTENSION TUBING SET |
| Product Code | OJA |
| Date Received | 2010-12-30 |
| Returned To Mfg | 2010-03-26 |
| Catalog Number | 6N8220 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | 600 MTS OESTE DE ENTRADA CARTAGO CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-30 |