MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-12-21 for LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET D-300 manufactured by Smiths Medical Asd, Inc..
[95529447]
It was reported that a leak on the y-connector of a level 1? Disposable normothermic iv administration set during intravenous and blood transfusion. The incident occurred immediately upon use. It was reported that there was no patient injury and no medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[116792030]
One y-connector of a level 1? Disposable normothermic iv administration set was returned for analysis in unused condition. The sample was visually inspected at a distance of 12" to 24". The returned sample was connected to an h-1200 hotline fluid warmer for functional testing. The sample leaked at the joint of the 3 "y" connector. A review of the manufacturing and inspection processes was conducted and was considered adequate and correct. The failure mode was leaking. The root cause was identified as a lack of robust and repeatable adhesive dispensing to achieve the desired adhesive depth and that the components were potentially not tested for leaks. See mfr: 3012307300-2017-02640, 3012307300-2017-02642.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-02641 |
| MDR Report Key | 7137835 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-12-21 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-09-01 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2017-12-21 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG |
| Manufacturer Street | S.A. DE C.V. AVE CALIDAD NO. 4 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, 22425 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2017-12-21 |
| Returned To Mfg | 2017-09-27 |
| Catalog Number | D-300 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-21 |