MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-12-19 for GEM CHECK COAG WHOLE BLOOD CONTROL 6260060600 manufactured by International Technidyne Corporation.
[4340302]
Healthcare facility reports end user was injured when using gem check coag whole blood control. Lab assistant sustained a small cut on her finger from a piece of glass that pierced through the control vial. The end user confirmed the protective sleeve was used during the crushing process to activate the control material and she wore gloves at all times. After activating the control, she subsequently removed the vial from the protective sleeve and held the vial to dispense the control material. The end user felt a stick on her finger, and noticed minor bleeding once removing her glove. The lab assistant was immediately evaluated by the hospital physician and the material safety data sheet was provided. No report of serious injury. This event occurred outside of the united states.
Patient Sequence No: 1, Text Type: D, B5
[11571773]
This mdr submitted (b)(4) 2013 references itc complaint #(b)(4). The gem check coag control is manufactured for instrumentation laboratory company. Instrumentation laboratory has submitted mdr # 1217183-2013-00017 to document this incident. Method: actual device not evaluated by (b)(4). Process evaluation performed by (b)(4). Device history records reviewed and found to meet release specifications. No related ncrs or current complaint trends identified. Result: no results available since no evaluation performed. Conclusion: human factors issue. The end user was not using the protective sleeve at the time of the injury and control material was expired. The protective sleeve is provided as a means to reduce probability of cuts. The instructions for use indicates use of protective sleeve is required when control vials are activated and while dispensing the control material. Each package includes an insert containing a picture demonstrating the preferred technique to use during activation of the vial. (b)(4) has requested all data required for form 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00008 |
| MDR Report Key | 3669749 |
| Report Source | 00,06 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-26 |
| Date of Event | 2013-11-20 |
| Date Mfgr Received | 2013-11-26 |
| Device Manufacturer Date | 2011-11-01 |
| Date Added to Maude | 2014-04-16 |
| 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 | ELEANOR FOX |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | EDISON NJ 08854 |
| Manufacturer Country | US |
| Manufacturer Postal | 08854 |
| Manufacturer Phone | 7325485700 |
| Manufacturer Street | 23 NEVSKY ST. |
| Manufacturer City | EDISON NJ 08820 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM CHECK COAG WHOLE BLOOD CONTROL |
| Product Code | GGN |
| Date Received | 2013-12-19 |
| Catalog Number | 6260060600 |
| Lot Number | M1GP3003 |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORPORATION |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-19 |