MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-26 for RUSCH NEOPRENE PECAN BAG 2L X 2 22170AP manufactured by Teleflex Medical.
[66131146]
(b)(4). A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report. No photo of the alleged defect was provided. A device history record review shows that the device was assembled and inspected according to our specifications. No conclusion can be established at this time based on the lack of device sample. It is necessary to have the physical sample in order to perform a proper investigation. Customer complaint cannot be confirmed. If the device sample becomes available at a later date, this investigation will be updated with the evaluation results.
Patient Sequence No: 1, Text Type: N, H10
[66131147]
Customer complaint alleges that the "neck pulls away from the bag". Alleged defect was reported as detected prior to use/ during pre-testing. No report of harm or injury. Patient condition reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00049 |
| MDR Report Key | 6280354 |
| Date Received | 2017-01-26 |
| Date of Report | 2017-01-16 |
| Date of Event | 2017-01-13 |
| Date Mfgr Received | 2017-01-16 |
| Device Manufacturer Date | 2016-03-02 |
| Date Added to Maude | 2017-01-26 |
| 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 | LINDA WOODALL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9196942566 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 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 | 0 |
| Brand Name | RUSCH NEOPRENE PECAN BAG 2L X 2 |
| Generic Name | BAG, RESERVIOR |
| Product Code | BTC |
| Date Received | 2017-01-26 |
| Catalog Number | 22170AP |
| Lot Number | 74C1600783 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-26 |