MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2013-11-12 for TENDERFOOT HEEL INCISION DEVICE TF501 manufactured by International Technidyne Corp..
[4052611]
Distributor reports end user was injured during use of the tenderfoot newborn heel incision device. While the end user was performing the heel stick procedure on an infant, the plastic casing halves of the device disassembled and end user received a cut from the exposed blade to her left ring finger. The hospital's needle stick injury procedure was followed, including reporting and blood specimen testing. At this time, no subsequent adverse events associated with this event have been reported to ptc. This event occurred outside of the united states.
Patient Sequence No: 1, Text Type: D, B5
[11481102]
Add'l expiration date: 04/2017. This mdr submitted 11/12/2013 (b)(4). The user facility reported two lot numbers. Be343m and bd354. However, the specific lot number which was used during the event that caused the injury was unable to be verified. Method codes, actual device involved in the event was not returned to itc. The user facility returned reopened product of lot #bd354. The customer-returned product of lot# bd354 abd itc's reserve samples for both lots (be343m and bd354) were evaluated. Device history records for both lot numbers (be343m and bd354) were reviewed and found product to meet release specs. No non-conformances or other anomalies identified. No current complaint trends was found for this product/issue. Result code: the complaint against lots (be343 and bd354) was not confirmed through the eval testing. Customer-returned samples for lot# bd354 and reserve samples of both lots (be343m and bd354) met specs. Itc has requested all data required for 3500a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2250033-2013-00007 |
| MDR Report Key | 3570088 |
| Report Source | 01,06,08 |
| Date Received | 2013-11-12 |
| Date of Report | 2013-10-15 |
| Date of Event | 2013-09-02 |
| Date Mfgr Received | 2013-10-15 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2014-02-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR FOX |
| Manufacturer Street | 20 CORPORATE PLACE SOUTH |
| Manufacturer City | PISCATAWAY 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 | TENDERFOOT HEEL INCISION DEVICE |
| Product Code | JCA |
| Date Received | 2013-11-12 |
| Returned To Mfg | 2013-10-29 |
| Catalog Number | TF501 |
| Lot Number | BE343M, BD354 |
| Device Expiration Date | 2017-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERNATIONAL TECHNIDYNE CORP. |
| Manufacturer Address | EDISON NJ 08820 US 08820 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-12 |