MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-08-18 for TMC HAND STRIPPER ME-HS manufactured by Terumo Medical Corporation.
[2157223]
A blood collection center reported that a staff member was sprayed with blood while evaluating a hand-stripper device. The following info was provided: "classroom" style training was being held to demonstrate the use of the terumo multi-function hand stripper device; staff members were given the opportunity to "test" the device on tubing connected to an empty, un-used blood bag; unbeknownst to the person conducting the demonstration, a staff member attempted to use the device on a unit that contained a recent donation; the tubing was cut / damaged somehow when the staff member attempted to strip a section of blood bag tubing, which resulted in blood spraying into the staff member's face and mouth; no face protection was being worn; management staff confirmed that the blood in the tubing was from a repeat donor with no known infectious diseases; and therefore, no medical treatment was deemed necessary for the staff member.
Patient Sequence No: 1, Text Type: D, B5
[9474569]
Conclusions - based upon eval of user facility info; based upon return sample eval. Examination of the returned sample determined that there were no defects or anomalies and the device operated properly w/o creating any damage to tubing during testing. A review of the complaint files confirmed that this lot has not been reported previously. In addition, there are no previous reports of a similar occurrence for any lot of this product family. Although the cause of the reported event cannot be definitely determined based upon the available info, the event description is most consistent with the tubing having been damaged as a result of user error. The terumo multi-function hand stripper device is a class i exempt device (ksd). All available info has been placed on file in quality assurance for appropriate tracking, trending, and f/u. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1118880-2011-00010 |
| MDR Report Key | 2258925 |
| Report Source | 05,06,07 |
| Date Received | 2011-08-18 |
| Date of Report | 2011-07-21 |
| Date of Event | 2011-07-21 |
| Date Facility Aware | 2011-07-21 |
| Report Date | 2011-07-21 |
| Date Reported to Mfgr | 2011-07-21 |
| Date Mfgr Received | 2011-07-21 |
| Device Manufacturer Date | 2011-03-23 |
| Date Added to Maude | 2012-06-21 |
| 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 | TIM REW, M.D., VP |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 4103927260 |
| Manufacturer G1 | TERUMO MEDICAL CORPORATION |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMC HAND STRIPPER |
| Product Code | KSD |
| Date Received | 2011-08-18 |
| Returned To Mfg | 2011-08-03 |
| Model Number | NA |
| Catalog Number | ME-HS |
| Lot Number | 110323 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 950 ELKTON BLVD. ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-18 |