MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-10-22 for PSI KIT: 8.5 FR X 4" (10 CM) NS-09803 manufactured by Arrow Intl., Inc..
[4983709]
It was reported the psi was being placed into the pt's internal jugular in the critical care unit. When attempting to remove the spring wire guide, the clinician felt resistance and thought the wire was caught on the needle. As a result, both the needle and guide wire were removed as one. A new kit was used to place the psi successfully. There was a delay in treatment with no pt harm and no pt death or complications were reported. It was noted the guide wire appeared to be freed upon removal.
Patient Sequence No: 1, Text Type: D, B5
[12446235]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00432 |
| MDR Report Key | 4207069 |
| Report Source | 07 |
| Date Received | 2014-10-22 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-17 |
| Date Mfgr Received | 2014-10-20 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2014-11-04 |
| 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 | ALICE HARPER |
| Manufacturer Street | 2400 BERNVILLE ROAD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6103780131 |
| Manufacturer G1 | ARROW INTL., INC. |
| Manufacturer Street | 312 COMMERCE PL. |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PSI KIT: 8.5 FR X 4" (10 CM) |
| Generic Name | INTERVENTIONAL PSI PRODUCTS |
| Product Code | DPN |
| Date Received | 2014-10-22 |
| Catalog Number | NS-09803 |
| Lot Number | 23F14D0890 |
| Device Expiration Date | 2016-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTL., INC. |
| Manufacturer Address | READING ND US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-22 |