MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-09-22 for LIFESHIELD CONNECTOR 11187 manufactured by Abbott Laboratories.
[200827]
Report received of leaking and bent needle resulting in an inadvertent needlestick to the health care professional. The nurse reported that while assessing an iv, it was observed to be leaking at the connection between the male adapter plug at the iv access site and the lifeshield connector. When the nurse removed the lifeshield connector, "the needle within was found bent at a 90 degree angle which resulted in a needle stick to the nurse. " the cause for the bent needle was undetermined. The nurse was treated per their hospital policy on blood exporsure. There was no adverse effect to the pt. No additional info was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018381-2000-00056 |
| MDR Report Key | 297965 |
| Report Source | 05 |
| Date Received | 2000-09-22 |
| Date of Report | 2000-08-25 |
| Date of Event | 2000-08-01 |
| Date Mfgr Received | 2000-08-25 |
| Date Added to Maude | 2000-09-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP, ASSOCIATE DIR |
| Manufacturer Street | 200 ABBOTT PARK RD DEPTARTMENT 37K,AP30 |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESHIELD CONNECTOR |
| Generic Name | CATHETER |
| Product Code | GCE |
| Date Received | 2000-09-22 |
| Returned To Mfg | 2000-08-31 |
| Model Number | NA |
| Catalog Number | 11187 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 288419 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | PO DRAWER 1009 LAURINBURG NC 28352 US |
| Baseline Brand Name | LIFESHIELD CONNECTOR |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 11187 |
| Baseline ID | NA |
| Baseline Device Family | ADAPTER, CATHETER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K912103 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-09-22 |