MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-07-24 for HUDSON PEDIATRIC BREATHING CIRCUIT, 30" 353801 manufactured by Teleflex.
[21170061]
The device history record of batch number 02h1301128 was reviewed and there were no issues or discrepancies found that could relate to the reported complaint. No non-conformance reports were originated for the lot in question. The dhr shows that the product was assembled and inspected according to specifications. The sample was received, however, the investigation results were not complete at the time of this report. A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[21239325]
It was reported by the distributor that circuits were pulled from stock and were found to be cracked at the end. The issue was detected prior to pt use during an inspection. Quantity = (b)(4) pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2014-00284 |
| MDR Report Key | 3994037 |
| Report Source | 01,07,08 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-10 |
| Date of Event | 2014-06-28 |
| Date Mfgr Received | 2014-07-10 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-08-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334854 |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO 88275 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88275 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON PEDIATRIC BREATHING CIRCUIT, 30" |
| Generic Name | ANESTHESIA BREATHING CIRCUIT |
| Product Code | OFP |
| Date Received | 2014-07-24 |
| Returned To Mfg | 2014-07-18 |
| Catalog Number | 353801 |
| Lot Number | 02H1301128 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | NUEVO LAREDO MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-24 |