MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-18 for WALKMED 204821 IPR-150 manufactured by Walkmed Infusion.
[83094404]
Two tube set leaks and a potential bag leak were noted by (b)(6) (1723533-2017-0013, 1723533-2017-0014, and 1723533-2017-0015).
Patient Sequence No: 1, Text Type: N, H10
[83094405]
(b)(6) submitted a complaint for a tubeset with a broken luer lock. Upon receipt of the returned devices, the luer locks were found to be cracked, likely due to cleaning with alcohol which degrades the material and is advised against. The bag being used at the time did not have any leaks. Incident occurred in the pharmacy cleaning room. Incident occured during cleaning, not during treatment. Confirmed no exposure to drug, there was no report of harm or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723533-2017-00015 |
| MDR Report Key | 6805273 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-18 |
| Date of Report | 2017-08-17 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2017-08-18 |
| 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 | MR/ THOMAS ASSANTE |
| Manufacturer Street | 14190 EAST JEWELL AVE UNIT 10 |
| Manufacturer City | AURORA CO 80012 |
| Manufacturer Country | US |
| Manufacturer Postal | 80012 |
| Manufacturer Phone | 7203514944 |
| Manufacturer G1 | REXMED |
| Manufacturer Street | FRESNEL # 8375 PARQUE INDUSTRIAL BERM |
| Manufacturer City | JUAREZ, CHIHUAHUA 32470 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32470 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALKMED |
| Generic Name | TUBE SET |
| Product Code | BTC |
| Date Received | 2017-08-18 |
| Returned To Mfg | 2017-08-17 |
| Model Number | 204821 |
| Catalog Number | IPR-150 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WALKMED INFUSION |
| Manufacturer Address | 14190 EAST JEWELL AVE UNIT 10 AURORA CO 80012 US 80012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-18 |