MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-29 for INFUSOR, PRESSURE, FOR I.V. BAGS IN900020 manufactured by Vyaire Medical, Inc.
[83859278]
No sample was provided for evaluation. If a sample or any additional information becomes available a follow up submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[83859279]
Customer reported via email:? Because of the stickiness of the plastic? It? S really difficult to slide it into the pressure bag? Almost a 5? Procedure to get into the bag, after their routine work around of flushing some of the fluid out of the bag to make it easier to slide in. 5? We are having run out as much as 100 ml out of the iv bag to get it into the pressure bag. One of the more surprising work around was putting lubricant on the outside of the bag to slide it in. The patient's bp was in the 50's or 70's.?
Patient Sequence No: 1, Text Type: D, B5
[109924437]
No physical sample was provided for this complaint. However, based on a similar report from the same facility with a sample evaluation the inspection showed that the sample conformed to the function and circumference test requirements. No abnormal measurement data was detected. No stickiness was observed on the pvc film of the return sample. This is the first complaint received for this issue. The returned sample was manufactured according to the requirement and conformed to the product specification. The cause of the reported issue cannot be identified. The supplier and vyaire medical will continue to monitor and trend for this issue. At this time no corrective actions can be implemented as the failure was unconfirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010838917-2017-00035 |
| MDR Report Key | 6826658 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-29 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-07-23 |
| Date Mfgr Received | 2017-11-24 |
| Date Added to Maude | 2017-08-29 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VINCENT MEDICAL |
| Manufacturer Street | 45-46 SHABU INDUSTRIAL ZONE, Q LONG DISTRICT, TANG XIA TOWN |
| Manufacturer City | DONG GUAN, GUANGDONG |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Generic Name | INFUSOR, PRESSURE, 1000 ML, CLEAR, 20/CS |
| Product Code | KZD |
| Date Received | 2017-08-29 |
| Catalog Number | IN900020 |
| Lot Number | 164592 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-29 |