MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for MINILOC SAFETY INFUSION SET 20G X 1 IN S02020-10 manufactured by Bard Access Systems.
[119654703]
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of asbus0197 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (asbus0197) have been reported from the same facility in (b)(4). Device has not yet been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[119654704]
It was reported that during the internal inspection, two device units had unidentified colorless materials blocking the infusion tubes. The devices were not used on a patient. This report addresses the first device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-02369 |
| MDR Report Key | 7852957 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-09-06 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD ACCESS SYSTEMS |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MINILOC SAFETY INFUSION SET 20G X 1 IN |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FON |
| Date Received | 2018-09-06 |
| Returned To Mfg | 2018-10-29 |
| Catalog Number | S02020-10 |
| Lot Number | ASBUS0197 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-06 |