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.
[179547930]
No information was provided. No patient/staff injury was alleged. Initial reporter's occupation is unknown. The sample has not been received by 3m st. Paul, mn for evaluation. Analysis is pending upon receipt of product. 3m is unable to verify the leak, identify exact location and root cause without the sample. Based on the information and product photos provided, the reported incident appears to be a solvent bond leak of the y-connector. Lot hx8321 was produced post corrective action of solvent application and volume uniformity. 3m will continue to monitor. End of report.
Patient Sequence No: 1, Text Type: N, H10
[179547931]
A hospital employee alleged a 3m? Ranger? High flow disposable set (model 24355) leaked saline fluid at the y-connection during priming on (b)(6) 2020 in the operating room. No pressure device or pump was used. New tubing and saline were used to prime a second set up. No patient or staff injury was alleged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00011 |
| MDR Report Key | 9712575 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-02-07 |
| 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 |
| 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 | HX8321 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 |