MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-06-06 for HUDSON BREATHING CIRCUIT, ANES, PED, 1.5 W/EXT H 313901 manufactured by Teleflex.
[4959621]
The event is reported as: the customer alleges that prior to use, a small crack on one of the ends of the circuit was discovered.
Patient Sequence No: 1, Text Type: D, B5
[11956777]
Two (2) pictures of a section of the product catalog number 313901 (breathing circuit, anes, ped, 1. 5m w/ext h) were received for analysis. They were visually inspected finding a crack in the corrugated tubing (b)(4) (corrugated tubing, 15x 22 mm, 60) as is described on the complaint description, this component is purchased from globalmed supplier. A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history record (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found related to this complaint. No non conformance reports were originated for the lot in question that can be associated to the complaint reported. The dhr shows that the product was assembled and inspected according to our specs. The customer complaint aas confirmed based on the visual inspection of the received pictures, because it was detected a crack on the corrugated tubing r/n (b)(4) (corrugated tubing, 15 x 22 mm, 60), at present time it is not possible to determine where the issue reported occurred, since this condition if 100% tested at production line on tp-0145 (leak test). However the current inventory that is in nl factory of p/n (b)(4) (corrugated tubing, 15 x 22 mm, 60) related to this complaint notification was inspected by the defect of "cracks" as it is described on this customer description, and no issues were detected. A notification of customer complaint was sent to the supplier of this component ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2014-00218 |
| MDR Report Key | 3998807 |
| Report Source | 01,06,07 |
| Date Received | 2014-06-06 |
| Date of Report | 2014-05-23 |
| Date of Event | 2014-05-21 |
| Date Mfgr Received | 2014-05-23 |
| Device Manufacturer Date | 2013-07-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN, REGULATORY AF |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer Street | AVE. TRANSFORMACION 5954 PARQUE INDUSTRIAL FINSA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON BREATHING CIRCUIT, ANES, PED, 1.5 W/EXT H |
| Generic Name | ANESTHESIA CIRCUIT |
| Product Code | OFP |
| Date Received | 2014-06-06 |
| Catalog Number | 313901 |
| Lot Number | 02F1300088 |
| 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 | 2014-06-06 |