MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-05-12 for MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4710P1 manufactured by Smiths Medical Asd, Inc..
[75052935]
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
[75052936]
It was reported that a medex? Clear-cuff pressure infusor did not hold pressure. It was noted the event "probably" occurred while in use with a patient. The fault occurred after the device had been cleaned "several (minimum four) times". No injury was reported. See mfr: 3012307300-2017-01022 and 3012307300-2017-01066.
Patient Sequence No: 1, Text Type: D, B5
[86861440]
Three used devices of unknown lot were received for evaluation without original packaging. Visual inspection of the devices determined the devices were assembled correctly per manufacturing specifications. One of the three devices was received with a broken manometer. Functional testing of the devices involved pumping the devices to 300mmhg and set for 24 hours to determine leakage. The device with the broken manometer was unable to be inflated. It was observed that the other two devices leaked and pressure dropped below 150mmhg. The source of the leakage was unable to be determined. A review of the complaint history identified similar complaints. A review of the device history record of the same product number identified that rework was conducted on leaking devices and a leaking problem had been identified due to a supplied cuff. Based on the evidence, it was determined that the complaint was confirmed and the root cause was attributed to a supplier issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01067 |
| MDR Report Key | 6563598 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-05-12 |
| Date of Report | 2017-06-12 |
| Date of Event | 2017-01-02 |
| Date Mfgr Received | 2017-06-01 |
| Date Added to Maude | 2017-05-12 |
| 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 INTERNATIONAL LTD. |
| Manufacturer Street | UNIT 4 BRADWOOD COURT ST. 1 CRISPIN WAY |
| Manufacturer City | ROSSENDALE, BB4 4PW |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BB4 4PW |
| 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 | 2017-05-12 |
| Returned To Mfg | 2017-05-11 |
| 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 | 2017-05-12 |