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 2017-02-08 for LEVEL 1? DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS DI-50 manufactured by Smiths Medical Asd, Inc..
[66827056]
Voluntary medwatch report #: mw5066816. The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10
[66827057]
It was reported that a level 1 disposable normothermic iv administration set double spike was detached from the drip chamber and the plastic was broken. The issue was observed when the product was opened initially. It was noted that there was no damage to the packaging prior to opening. It was initially reported that the product did not reach the patient, but then it was reported that a serious injury occurred. It was unclear what the impact to the patient was.
Patient Sequence No: 1, Text Type: D, B5
[111367315]
One photo was returned for evaluation. Photographic inspection found that the drip chamber was separated from the 3-day y connector and that the inlet of the single port cap was broken. One device was returned for evaluation in used condition and without its original packaging. A review of the testing and inspection documents was performed and deemed adequate and correct. A review of the manuafacturing process was performed on a similar part. A sample of 32 devices was taken for visual inspection and found no discrepancies. Functional testing involved simulated use testing with 4 device samples with excess solvent and was found to be bent and not broken. Functional testing involved a pull test with 4 device samples and found the samples completely split as the complaint device did. Based on the evidence, the root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-00488 |
| MDR Report Key | 6312295 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-08 |
| Date of Report | 2017-10-31 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2017-10-12 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2017-02-08 |
| 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 | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS HEALTHCARE MFG |
| Manufacturer Street | S.A. DE C.V. AVE CALIDAD NO. 4 PARQUE INDUSTRIAL INTERNACIONA |
| Manufacturer City | TIJUANA, B.C. 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 SETS |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2016-11-28 |
| Catalog Number | DI-50 |
| Lot Number | 3189735 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2017-02-08 |