MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for ARROW HEMODIALYSIS SET: 2-LUMEN 9 FR X 13 CM CD-13902 manufactured by Arrow International Inc..
[186730884]
Qn#: (b)(4). Preliminary evaluation of the returned device indicates swg/needle resistance unraveled.
Patient Sequence No: 1, Text Type: N, H10
[186730885]
It was reported that the doctor alleges that the wire guide got stuck in the needle while catheterizing. The doctor could not pull it out. Clinical consequences: device was removed, and new set opened and used successfully. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00296 |
| MDR Report Key | 9885770 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2020-03-30 |
| Device Manufacturer Date | 2019-03-27 |
| Date Added to Maude | 2020-03-26 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW HEMODIALYSIS SET: 2-LUMEN 9 FR X 13 CM |
| Generic Name | CATHETER, HEMODIALYSIS, NON-I |
| Product Code | MPB |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-09 |
| Catalog Number | CD-13902 |
| Lot Number | 71F19C2516 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |