MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-29 for PORTEX LATEX-FREE HYPERINFLATION SYSTEMS 008330DM manufactured by Smiths Medical International Ltd.,.
[5917339]
A report was received stating that the bag disintegrated during use. The bag would not inflate due to breakage at the neck of the device. There was no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[13342923]
Device evaluation: smiths medical has received the sample device. A full evaluation is anticipated, but not yet began as the device is currently in transit to the investigation site. 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
[13513107]
Device evaluation: one used sample was returned for evaluation. Visual inspection confirmed the tear in the bag. The bag also appeared to have scratches present in some areas. A 100% visual inspection is performed during the assembly practice. The condition of the returned sample would have been easily detected during the inspection process. Unable to determine root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00384 |
| MDR Report Key | 4815023 |
| Report Source | 06 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-27 |
| Report Date | 2015-05-27 |
| Date Reported to FDA | 2015-05-27 |
| Date Mfgr Received | 2015-05-08 |
| Device Manufacturer Date | 2014-10-20 |
| Date Added to Maude | 2015-06-25 |
| 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 | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287604 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD., |
| Manufacturer Street | BOUNDRY ROAD |
| Manufacturer City | HYTHE,KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX LATEX-FREE HYPERINFLATION SYSTEMS |
| Generic Name | NHK-HYPERINFLATION BAG SYSTEM |
| Product Code | NHK |
| Date Received | 2015-05-29 |
| Returned To Mfg | 2015-05-22 |
| Model Number | NA |
| Catalog Number | 008330DM |
| Lot Number | 2806444 |
| ID Number | NA |
| Device Expiration Date | 2017-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL LTD., |
| Manufacturer Address | HYTHE,KENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-29 |