MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-19 for 20ML SYR LUER LOCK TIP 1182000777 manufactured by Covidien.
[184102371]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.? If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[184102372]
The customer reported the medication propofol dripped out of the luer lock syringe, when the anesthesiologist went to put the syringe on the iv tubing. The incident was occurred when ready to inject into the patient. The plunger was not staying in place once deployed to deliver medication, resulting in the medication to come out the back end of the syringe. There was a chemical exposure in the patient's eye. The patient was reported to be asymptomatic, when asked in the recovery area by the anesthesiologist involved in the case. The anesthesiologist irrigated the effected eye with copious amounts of normal saline in additional to eye. The patient was believed to be discharged from the post-anesthesia care unit (pacu) area without any reported symptoms or complications with the eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1915484-2020-01144 |
| MDR Report Key | 9853251 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 1222 SHERWOOD RD |
| Manufacturer City | NORFOLK NE 68701 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68701 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 20ML SYR LUER LOCK TIP |
| Generic Name | SYRINGE, PISTON |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Model Number | 1182000777 |
| Catalog Number | 1182000777 |
| Lot Number | 907769X |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 1222 SHERWOOD RD NORFOLK NE 68701 US 68701 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |