MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-14 for 3M? RANGER? HIGH FLOW DISPOSABLE SET N/A 24355 manufactured by 3m Health Care.
[182294031]
Patient information: no information was provided. No patient or staff injury was alleged. Date of event: exact date of event not provided. Reporter indicated event occurred in (b)(6) 2020. The sample was not available for evaluation. 3m is unable to verify the leak, identify exact location and root cause without the sample. Based on the provided information, the reported incident appears to have occurred due to solvent bond failure. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[182294032]
A hospital crna in (b)(6) reported that in (b)(6) 2020 the anesthesia department discovered a 3m? Ranger? High flow disposable set (model 24355) leaked ringer's solution fluid directly below the drip chamber. A 3m? Ranger? Warming unit (model 24510) was used to warm the set. No pressure device or pump was used. No patient or staff injury was alleged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00012 |
| MDR Report Key | 9712577 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 7379117 |
| Manufacturer G1 | NYPRO PRECISION ASSEMBLIES |
| Manufacturer Street | SOR JUANA INES DE LA CRUZ CD. INDUSTRIAL |
| Manufacturer City | TIJUANA, 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? RANGER? HIGH FLOW DISPOSABLE SET |
| Generic Name | HIGH FLOW DISPOSABLE TUBING |
| Product Code | BSB |
| Date Received | 2020-02-14 |
| Model Number | N/A |
| Catalog Number | 24355 |
| Lot Number | HX8341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |