MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-10 for 3M? RANGER? HIGH FLOW DISPOSABLE SET N/A 24355 manufactured by 3m Health Care.
[182293849]
Patient information: no information was provided. Date of event: exact date of event(s) were not provided. Report date of (b)(6) 2020 was used as the d. O. E. Analysis is pending on returned sample. The reported leak appears to have occurred due to solvent bond failure. Supplier corrective action request (scar) was issued to address solvent bond failures is in the qualification phase. 3m will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
[182293850]
A hospital employee alleged two 3m? Ranger? High flow disposable sets (model 24355) leaked fluid around the y-connection tubing, before the drip chamber. Exact incident dates were not specified. The facility's transport nurse alleged, during the first incident, she discovered blood had leaked from the set. The nurse taped around the y-connection after discovering the leak. The set was reportedly not under pressure. The nurse alleged, during the second incident, she discovered a leak prior to connecting the tubing to a patient. Device usage details were provided. No patient or staff injury was alleged. No further details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00005 |
| MDR Report Key | 9688939 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-02-10 |
| 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 | 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 | 2020-02-10 |
| Returned To Mfg | 2020-01-29 |
| Model Number | N/A |
| Catalog Number | 24355 |
| Lot Number | HX8427 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-10 |