MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-17 for KIT: BONE MARROW DA 20/CS 59947B manufactured by Medical Action Industries.
[26047695]
Upon receipt of the (b)(6) 2015 complaint, mai opened an internal complaint investigation under (b)(4). Mai evaluated the tracking and trending database for similar occurrences or related complaints, but had not received any prior complaints for this component or kit. This component (lidocaine 30ml glass vial) is manufactured and supplied to mai by (b)(4). Mai places the 30ml lidocaine vial into a protective pouch and attaches it to the exterior of the mai-assembled bone marrow kit after the kit has been sterilized. Mai did revise the kit components per customer discussion and approval to change the 30ml glass lidocaine vials and instead implement the use of (2) plastic 20ml lidocaine solution vials. The hospital was accustomed to using these particular style vials previously. The supplier, (b)(4), was notified of the received complaint and will be addressing this issue further as well by conducting an internal (b)(4). At this time, their investigation has not concluded or identified any product defect information.
Patient Sequence No: 1, Text Type: N, H10
[26047696]
Medical action industries (mai) manufactures a bone marrow tray containing lidocaine manufactured by (b)(4). On (b)(6) 2015, mai received a complaint from ohio state university medical center regarding the lidocaine. The hospital reported that the lidocaine vial cap blew off the vial when the technician was adding air to the medication vial before drawing out the medication. As a result, the hospital reported that lidocaine splashed into the eye of the lab technician. The injured employee was treated with a neutralizing agent by the medical center's emergency department, then subsequently released. The customer was unable to provide a complaint lot number for the associated product. According to the hospital, this is the second incident involving lidocaine provided in a mai-manufactured bone marrow tray. The first incident was not initially reported to mai by the hospital and was only a comment from an employee that stated this lidocaine vial was a problem but no injury or further details attributed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2015-00003 |
| MDR Report Key | 5084155 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-14 |
| Date of Event | 2015-08-13 |
| Date Facility Aware | 2015-08-19 |
| Date Mfgr Received | 2015-08-19 |
| Date Added to Maude | 2015-09-17 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS NICHOLE EARLY |
| Manufacturer Phone | 8283387567 |
| Manufacturer G1 | MEDICAL ACTION INDUSTRIES |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28704 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT: BONE MARROW DA 20/CS |
| Generic Name | BONE MARROW TRAY |
| Product Code | LWE |
| Date Received | 2015-09-17 |
| Model Number | 59947B |
| Catalog Number | 59947B |
| Lot Number | UNKNOWN |
| Operator | HOSPITAL SERVICE TECHNICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-17 |