MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for ARROW CDC-42802XP1A manufactured by Teleflex Incorporated.
[184847542]
During placement of a left subclavian central line by a surgeon, when the guide wire was pulled out after placing the catheter, it was difficult to remove. When removed, the wire was found to be frayed/unraveled. A new guide wire was used to ensure correct placement of the catheter and a chest x-ray was taken to look for any part of the guide wire that may have been retained. Per the radiologist, "no metallic radiopaque foreign body identified". Packaging and wire given to manager and sequestered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877349 |
| MDR Report Key | 9877349 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-14 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM |
| Product Code | FOZ |
| Date Received | 2020-03-25 |
| Model Number | CDC-42802XP1A |
| Lot Number | 23F19J008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |