MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-14 for DEK BL MF 0 TC-43/HR 26 2N 36" 833-124 manufactured by Teleflex Medical.
[70102906]
(b)(4). An attempt to duplicate the failure mode was made but without satisfactory results if defective samples become available at a later date, this complaint will be updated accordingly. The device history record of batch number 74h1600336 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint. No rejection report was originated for the lot in question that can be associated to the complaint reported; the product was assembled and inspected according to the manufacturer's specifications. The customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[70102907]
The bullet tip came off in the patient and it was not retrieved. The patient's condition was reported as unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2017-00100 |
| MDR Report Key | 6402325 |
| Date Received | 2017-03-14 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2016-08-02 |
| Date Added to Maude | 2017-03-14 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| 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 | DEK BL MF 0 TC-43/HR 26 2N 36" |
| Product Code | MFJ |
| Date Received | 2017-03-14 |
| Returned To Mfg | 2017-07-11 |
| Catalog Number | 833-124 |
| Lot Number | 74H1600336 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-03-14 |