MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-20 for WNTHRP CPJT HOLDERS 2ML/5ML (F) 02049 manufactured by Hospira, Inc..
[3905728]
The pt reported device breakage. The pt reported that the carpuject holder was being used to deliver heparin sodium 5,000u/0. 5 ml every 8 hours, via self-administered subcutaneous injections. On (b)(6) 2013 at 0800, it was reported that while a prefilled medication cartridge was being loaded into the carpuject holder, the device "collapsed" in the pt's hand. On (b)(6) 2013, the pt reported that the heparin therapy was not administered. On (b)(6) 2013, the device was replaced and the therapy was resumed. There were no reported adverse pt effects and no reported delay of therapy critical to this pt. No medical interventions were required. Though requested, no add'l info was provided.
Patient Sequence No: 1, Text Type: D, B5
[11161391]
The pt indicated that the device was discarded. During the investigation, no possible causes for the customer reported device breakage were identified. The device was not returned to hospira for testing and investigation; therefore, attribution of the issue to the device could not be determined. This report represents all the info known by the reporter upon query by hospira personnel.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1925262-2013-00001 |
| MDR Report Key | 3410581 |
| Report Source | 04 |
| Date Received | 2013-09-20 |
| Date of Report | 2013-08-23 |
| Date of Event | 2013-08-23 |
| Date Mfgr Received | 2013-08-23 |
| Date Added to Maude | 2013-12-30 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUREGEN SCHMIDER, MD, VP, GPS |
| Manufacturer Street | 275 N. FIELD DRIVE BLDG H2-1EAST, DEPT NO. 097U |
| Manufacturer City | LAKE FOREST IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 2242125740 |
| Manufacturer G1 | HOSPIRA, INC. |
| Manufacturer Street | 1776 N. CENTENNIAL DR. PO BOX 1247 |
| Manufacturer City | MCPHERSON KS 67460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 67460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WNTHRP CPJT HOLDERS 2ML/5ML (F) |
| Generic Name | 80IQG |
| Product Code | IQG |
| Date Received | 2013-09-20 |
| Model Number | NA |
| Catalog Number | 02049 |
| Lot Number | UNKLL |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Manufacturer Address | 1776 NORTH CENTENNIAL DR. MCPHERSON KS 67460 US 67460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-20 |