MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-28 for LIFESHIELD CONNECTOR 11187 manufactured by Abbott Laboratories.
[18223405]
The customer contact reported the device was "bent" resulting in a delay in critical therapy. The device was being used to cross the y-site of an unspecified tubing set that was delivering an unspecified concentration of dopamine at a rate of 20mcg/kg/min. After an unspecified length to time after the y-site was accessed using the device, leakage was reported from a "large hole in the port" of the unspecified tubing set. Reportedly, "the needle tip is bent" and a hole in the port was noted. It was reported that the pt "did not have optimal blood pressure as the needed medication was infusing onto the bed. " the tubing set was replaced and therapy was resumed. No medical intervention were required. There were no reported adverse pt sequelae. Though requested, no add'l info was provided.
Patient Sequence No: 1, Text Type: D, B5
[18356178]
The customer indicated that the device was discarded. A rep device from lot #851155h was received. Investigation is not complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018381-2008-00001 |
| MDR Report Key | 1151010 |
| Report Source | 05 |
| Date Received | 2008-08-28 |
| Date of Report | 2008-08-04 |
| Date of Event | 2008-07-14 |
| Date Mfgr Received | 2008-08-04 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2009-02-17 |
| 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 | STEVEN COX, DIR |
| Manufacturer Street | 8401 W 102ND ST, DEPT NO 097U BLDG NO HW1, STE 300 |
| Manufacturer City | PLEASANT PRAIRIE WI 53158 |
| Manufacturer Country | US |
| Manufacturer Postal | 53158 |
| Manufacturer Phone | 2625776072 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | PO DRAWER 1009 |
| Manufacturer City | LAURINBURG NC 28352 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28352 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESHIELD CONNECTOR |
| Generic Name | 79-GCE |
| Product Code | GCE |
| Date Received | 2008-08-28 |
| Returned To Mfg | 2008-08-19 |
| Model Number | NA |
| Catalog Number | 11187 |
| Lot Number | 73169HG |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | PO DRAWER 1009 LAURINBURG NC 28352 US 28352 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-28 |