MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-06-14 for MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4710P1 manufactured by Smiths Medical Asd, Inc..
[77560492]
Potential lot numbers - 1375586, 2318203, 2520828,2641407, 2731314, 3031202, 3166207, 3277472, 3290524, 3330092, and 3333628. Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[77560493]
It was reported that air leaked from a medex? Clear-cuff pressure infusor, and the device does not hold pressure. It was also noted that there were visible cracks on the "light blue plastic part". No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[104524148]
The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event. One sample was received for evaluation. Based on the reported information, it was not possible to determine which of the reported lot numbers were impacted by the alleged device deficiency. Functional testing was performed to detect for any possible leakage. The unit was pressurized to 300mhg. After 24 hours, the sample should have retained pressure between 300 mmhg and 150 mmhg. The sample did not retain the required pressure. The complaint was confirmed. The root cause to the reported issue has been attributed to a supplied component. An in-house 100 percent leak test performed during manufacturing had been implemented after the reported potential lots were released for distribution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01257 |
| MDR Report Key | 6641088 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-06-14 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-05-12 |
| Date Mfgr Received | 2017-10-03 |
| Date Added to Maude | 2017-06-14 |
| 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 CZECH REPUBLIC A. S. |
| Manufacturer Street | OLOMOUCK HRANICE 1 - MESTO |
| Manufacturer City | HRANICE, 753 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 753 01 |
| 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 | 2017-06-14 |
| Returned To Mfg | 2017-07-06 |
| Catalog Number | MX4710P1 |
| 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 | 2017-06-14 |