MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-05-16 for MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4705 manufactured by Smiths Medical Asd, Inc..
[75322652]
The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10
[75322653]
It was reported that a medex? Clear-cuff pressure infusor had burrs and was leaking. No injury was reported. See mfr: 3012307300-2017-01012, 3012307300-2017-01077, 3012307300-2017-01078, 3012307300-2017-01079, 3012307300-2017-01081, 3012307300-2017-01082, 3012307300-2017-01083, 3012307300-2017-01084, 3012307300-2017-01085, and 3012307300-2017-01086, and 3012307300-2017-01087.
Patient Sequence No: 1, Text Type: D, B5
[86861746]
Twelve devices were received for evaluation. Visual inspection of the devices discovered small burrs on the side of the bags. Functional testing involved a leak test and all twelve devices were inflated and left overnight; it was observed that the devices held the same amount of air that the devices were inflated with, and therefore the leaking was not observed. A review of the manufacturing process identified that dies that were used to cut the device were dull and needed adjustment, which was corrected prior to the production of the reported lot. Based on the evidence, the complaint was unable to be confirmed. The returned device functioned as specified. There was no evidence to indicate that there was an intrinsic defect in the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01080 |
| MDR Report Key | 6569182 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-05-16 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-04-18 |
| Date Mfgr Received | 2017-05-30 |
| Device Manufacturer Date | 2016-11-15 |
| Date Added to Maude | 2017-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC. |
| Manufacturer Street | 6250 SHIER RINGS ROAD |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX? CLEAR-CUFF PRESSURE INFUSOR |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-05-16 |
| Returned To Mfg | 2017-05-10 |
| Catalog Number | MX4705 |
| Lot Number | 3317569 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-16 |