MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for MEDICHOICE CIR1005 manufactured by Medical Action Industries.
[61698742]
(b)(4) received above stated report on 11/08/2016 regarding metal flakes from hemostat component falling on patient wound during circumcision procedure. (b)(4) is the manufacturer of the convenience kit which contains this instrument. The hemostat instrument, vendor number 160, is manufactured in (b)(4). Upon receipt of complaint, (b)(4) initiated an internal complaint investigation under complaint (b)(4). We obtained the involved sample for evaluation and initiated a supplier corrective action request with the manufacturer of the instrument. The supplier, (b)(4), has responded that the instrument did not appear to have fully removed the cleaning compound from this instrument at one location on the instrument during ultrasonic machine precleaning processes. The debris appeared to be cleaning compound rather than metal flakes. The manufacturer has evaluated the precleaning process and extended instrument time within ultrasonic cleaning machine to further ensure all remaining manufacturing debris is fully removed. The supplier additionally did inspect all inventory and did not find any other nonconforming product. Mai reviewed complaint history for this kit and instrument and found no other similar complaints of this nature in the past three years. Mai evaluated a lot from current inventory as well and found no nonconforming product. At this time, this instance appears to be isolated in nature.
Patient Sequence No: 1, Text Type: N, H10
[61698743]
(b)(4) received report on 11/03/2016 that a hemostat used in circumcision procedure had some metal flake off during procedure. Follow-up with the end-user indicated there was no patient harm associated with the incident. The instance occurred during use of instrument and the flakes were on patient wound and removed by physician. (b)(4) assembled/manufactured the involved convenience kit, cir1005. In this instance, the hemostat instrument involved was originally manufactured by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2016-00016 |
| MDR Report Key | 6153062 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-11-03 |
| Date Facility Aware | 2016-11-08 |
| Date Mfgr Received | 2016-11-08 |
| Device Manufacturer Date | 2016-02-16 |
| Date Added to Maude | 2016-12-07 |
| 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 | NICHOLE EARLY |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8283387568 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICHOICE |
| Generic Name | CIRCUMCISION KIT |
| Product Code | OHG |
| Date Received | 2016-12-07 |
| Returned To Mfg | 2016-11-10 |
| Model Number | CIR1005 |
| Lot Number | 217987 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-07 |