MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2013-06-17 for HUDSON ADULT ANESTHESIA CIRCUIT, 40" 359103 manufactured by Teleflex Medical.
[21946096]
The actual lot numbers are unk. The suspect lot numbers are reported as: 02d1102812, 02e1001965, 02h1002326, 02j1002682 and 02l1100768. A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned. The device history records of batch numbers 02d1102812, 02e1001965, 02h1002326, 02j1002682 and 02l1100768 have been reviewed and no issues or discrepancies were found related to this complaint. No nonconformance reports were originated for the lot in question that can be associated to the complaint reported. Dhr shows that the product was assembled and inspected according to our specifications. Customer complaint cannot be confirmed since the defective sample or a picture of it are unavailable to perform a proper investigation and determine the root cause. However based on a similar complaint the root cause could be related to the molding process of the fitting adaptor (p/n (b)(4)), a slow injection process of the resin into the mold could cause that the weld line was not strong enough, causing a crack when the fitting adaptor was stressed. Currently, this product code is running on the nl003 which is the machine that is validated under the decouple method. The actual inventory of the fitting adaptors belongs to this machine and was inspected by the defect.
Patient Sequence No: 1, Text Type: N, H10
[21986439]
The complaint was reported as: the customer alleges that the connectors of the anesthesia bags for the anesthesia circuit system were found cracked. No report of patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2013-00200 |
| MDR Report Key | 3181893 |
| Report Source | 01,06,08 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-05-24 |
| Date of Event | 2013-04-19 |
| Date Mfgr Received | 2013-05-24 |
| Date Added to Maude | 2013-09-11 |
| 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 | MARGIE BURTON, RA CLINICAL SPEC |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA |
| Manufacturer City | NUEVO LAREDO, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON ADULT ANESTHESIA CIRCUIT, 40" |
| Generic Name | ANESTHESIA CIRCUIT |
| Product Code | BSJ |
| Date Received | 2013-06-17 |
| Catalog Number | 359103 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA NUEVO LAREDO, TAMAULIPAS MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-17 |