MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-02-26 for 3M? RANGER? HIGH FLOW DISPOSABLE SET N/A 24355 manufactured by 3m Health Care.
[182295694]
Patient information: no information was provided. Report source: 3m was notified of this event via fda sus voluntary event report mw5092206. 3m has made multiple attempts to obtain further information on this reported event. No sample was returned for evaluation. Without the sample or product photos, 3m is unable to verify exact leakage location. Root cause of reported issue was not established. Based on the information provided,the probable cause of the leak is due to solvent bond failure. Corrective action has been issued to address solvent bond leaks. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[182295695]
A hospital employee reported via a fda sus voluntary event report that a patient was in need of an emergent blood transfusion on (b)(6) 2020. A 3m? Ranger? High flow disposable set (model 24355) was used. A unit of non-screened blood reportedly hung in the rapid transfuser. The line was then flushed with normal saline. The employee alleged that when starting blood pressure, the tubing broke where it meets the filter. Blood reportedly poured onto the floor. No harmful exposure to blood was specified. No patient or staff injury was specified. Patient's current condition is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00014 |
| MDR Report Key | 9759118 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2018-10-18 |
| Date Added to Maude | 2020-02-26 |
| 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 | RISK MANAGER |
| 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 | 2020-02-26 |
| Model Number | N/A |
| Catalog Number | 24355 |
| Lot Number | HX8246 |
| 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 | 2020-02-26 |